Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032109181

FEI Number

3032109181

Entity Name

WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED

City/State/Country

Bangalore Karnataka, IN

Establishment Address

No. 4 Kadugodi Industrial Area, Sadarmangala, Whitefield, Bangalore Karnataka 560067, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251963

PMA Number

N/A

All Registered Proprietary Names

Auto Positioning L8-18i-RS C1-5-RS L4-12t-RS 12L-RS L10-22-RS Venue Go E8C-RS 9L-RS 8C-RS 6S-RS 3Sc-RS 12S-RS ML6-15-RS L4-20t-RS 6Tc-RS P6D 8C Vivid E95 11L-D C1-6-D L8-18i-D Vivid E80 9T C3-10-D 9T-RS C2-9-D 4V-D Vivid E90 M5Sc-D 6S-D 6Tc-RS P2D 9L-D iC5-9-D 12S-D 6VT-D 6S-D 10T-D Vivid E90 M5Sc-D 12S-D 11L-D 6Tc-RS 9T-RS iC5-9-D 9L-D C2-9-D 9T Vivid E95 ML6-15-D 6VT-D C3-10-D P2D 4V-D P6D 8C Vivid E80 C1-6-D L8-18i-D 6Vc-D 4Vc-D ML6-15 9L-D 6S-D C1-6-D 8C 11L-D IC5-9-D BE9CS BE9CS-D C1-5-D L3-12-D P6D P2D LOGIQ S7 Expert RIC5-9-D RAB4-8-D L8-18i-D 6Tc-RS C3-10-D L10-22-RS 12S-RS 6Tc-RS L8-18i-RS L4-20t-RS Venue Go C2-9-RS 6S-RS E8C-RS M5Sc-RS Venue L12n-RS ML6-15-RS 12L-RS L4-12t-RS 3Sc-RS 8C-RS C1-5-RS Venue Sprint 9L-RS Venue Fit ML6-15-D P6D C2-9-D RIC5-9-D LOGIQ E10s R2R3 to R4 SW Upgrade W M5Sc-D LOGIQ Fortis R3 to R4 SW Upgrade W BE9CS-D P2D L3-12-D IC5-9-D C2-9VN-D L4-20t-D RAB6-D 6Tc-RS LOGIQ Fortis ML4-20VN-D L2-9VN-D LOGIQ E10s R2R3 to R4 SW Upgrade LOGIQ E10s 6S-D C1-6VN-D L2-9-D ML4-20-D LOGIQ Fortis R3 to R4 HW Upgrade C3-10-D LOGIQ Fortis R3 to R4 HW Upgrade W LOGIQ E10s R2R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 SW Upgrade C1-6-D L8-18i-D LOGIQ E10s R2R3 to R4 HW Upgrade W 9T-RS M5Sc-RS 6Tc-RS E8Cs-RS C1-5-RS Vivid iq L8-18i-RS 4C-RS ML6-15-RS 6VT-D 9L-RS 6S-RS P2D 12S-RS 12L-RS 3Sc-RS 8C-RS E8C-RS L8-18i-RS 6Tc-RS 9L-RS 3Sc-RS L4-12t-RS 8C-RS C1-5-RS 12L-RS Venue Go 6S-RS L8-18i-RS LK760-RS 6S-RS L6-12-RS 4C-RS Versana Balance 12L-RS 8C-RS RAB2-6-RS E8C-RS 3Sc-RS 12S-RS E8Cs-RS MAC 5 A4 MAC 5 A4 Resting ECG Analysis System MAC 5 A5 MAC 5 Lite Resting ECG Analysis System MAC 5 Lite MAC 5 A5 Resting ECG Analysis System SIGNA Prime Elite Optima CT680 Expert Revolution Maxima Revolution Ace Console Generation Upgrade E8C-RS 12L-RS LK760-RS Versana Premier E8Cs-RS 6S-RS 8C-RS L6-12-RS RIC5-9A-RS 4C-RS L8-18i-RS RAB2-6-RS 3Sc-RS 12S-RS C1-5-RS L6-12-RS Vivid T8 8C-RS 4C-RS 3Sc-RS 9T-RS 12L-RS 6S-RS 6Tc-RS L8-18i-RS 9L-RS P2D 12S-RS E8C-RS LOGIQ S20 LOGIQ S20 Express C1-6VN-D ML6-15-D 12S-D M5Sc-D C2-9VN-D LOGIQ Vita Power L8-18i-D L2-9VN-D LOGIQ Vita Express P2D L4-20t-D P6D IC5-9-D L2-9-D LOGIQ S20 Plus 6Tc-RS RIC5-9-D LOGIQ S20 Pro LOGIQ Vita Plus LOGIQ S20 Power RAB6-D LOGIQ Vita L3-12-D C1-6-D 6S-D C2-9-D C3-10-D BE9CS-D LOGIQ Vita Pro 3Sc-RS L8-18i-RS ML6-15-RS L4-12t-RS 12L-RS 9L-RS L4-20t-RS 12S-RS L10-22-RS 6Tc-RS LOGIQ e 8C-RS 6S-RS 4C-RS E8C-RS C1-5-RS LK760-RS Versana Premier 8C-RS 12L-RS 12S-RS RAB2-6-RS L8-18i-RS 3Sc-RS 6S-RS RIC5-9A-RS E8C-RS 4C-RS L6-12-RS E7C8L-RS BE9CS-RS E8Cs-RS C1-5-RS Voluson P6 E8C-RS 12L-RS RAB2-6-RS 4C-RS 3Sc-RS Voluson P8 RIC5-9A-RS IC9-RS Voluson E6 Voluson E8 P2D C1-5-D eM6C G2 9L-D C1-6-D RAB6-D L2-9-D IC5-9-D RM7C C4-8-D Voluson E10 RSP6-16-D RM6C 11L-D C2-9-D ML6-15-D RAB2-5-D eM6C G3 RNA5-9-D RIC6-12-D eM6C P6D IC9-D RIC5-9-D M5Sc-D 12L-RS Venue 6Tc-RS 9L-RS C1-5-RS E8C-RS 8C-RS L8-18i-RS 3Sc-RS L12n-RS L4-12t-RS 6S-RS L8-18i-RS E8Cs-RS 12S-RS Versana Premier 6S-RS LK760-RS E7C8L-RS 4C-RS L3-12-RS L6-12-RS C1-5-RS BE9CS-RS 12L-RS RIC5-9A-RS RAB2-6-RS E8C-RS 3Sc-RS 8C-RS 9L-RS P6D Voluson E8 11L-D Voluson E series BT15 Voluson E6 RIC5-9-D IC5-9-D RAB6-D RSP6-16-D Voluson E10 C4-8-D ML6-15-D eM6C RNA5-9-D RAB2-5-D RIC6-12-D P2D RM6C Voluson E series C1-5-D 9L-D 12L-RS L10-22-RS ML6-15-RS 12S-RS L8-18i-RS 8C-RS L4-20t-RS C1-5-RS 3Sc-RS Venue Fit M5Sc-RS 9L-RS L4-12t-RS 6Tc-RS 6S-RS E8C-RS 9T C2-9-D ML6-15-D 9L-D Vivid E95 4Vc-D Vivid E80 4V-D M5Sc-D C3-10-D 9VT-D 10T-D 6S-D 6Vc-D P2D Vivid E90 8C iC5-9-D 6VT-D 12S-D L8-18i-D P6D 11L-D C1-6-D 9T-RS 6Tc-RS E8Cs-RS E8C-RS LK760-RS L6-12-RS 3Sc-RS 6S-RS 4C-RS 8C-RS L8-18i-RS 9L-RS Versana Active 12S-RS 12L-RS 6S-RS E8Cs-RS L6-12-RS E8C-RS Versana Essential RAB2-6-RS 8C-RS 3Sc-RS LK760-RS 4C-RS L4-12t-RS ML6-15-RS 12S-RS M5Sc-RS Venue L4-20t-RS 3Sc-RS L12n-RS 6S-RS L10-22-RS 8C-RS 12L-RS C1-5-RS C2-9-RS L8-18i-RS 6Tc-RS E8C-RS 9L-RS E8CS-RS L10-22-RS 4C-RS L6-12-RS RIC5-9A-RS C1-5-RS L8-18i-RS LOGIQ P9 8C-RS L4-12t-RS 12S-RS 9L-RS P6D LOGIQ P7 L12n-RS BE9CS-RS IC9-RS 3Sc-RS 6S-RS P2D L3-12-RS 6Tc-RS 12L-RS RAB2-6-RS ML6-15-RS RAB2-6-RS RAB4-8-RS Voluson i E8C-RS 8C-RS Voluson e RAB2-5-RS 4C-RS RIC5-9W-RS RNA5-9-RS 12L-RS 9L-RS ML6-15-D IC5-9-D L2-9VN-D L2-9-D C1-6VN-D L3-12-D C2-9VN-D 6S-D L8-18i-D LOGIQ E10 RAB6-D 6Tc-RS RIC5-9-D ML4-20-D M5Sc-D ML4-20VN-D C3-10-D P6D BE9CS-D C2-9-D P2D C1-6-D 6Tc-RS 12S-D C2-9-D iC5-9-D 8C 9T-RS 9T P2D 11L-D Vivid E90 4V-D C1-6-D P6D L8-18i-D Vivid E95 6VT-D 9L-D 6S-D M5Sc-D Vivid E80 10T-D B1X5-F2, Second Frame B125M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M Monitor B155M B125P Patient Monitor Monitor B125P B105M Patient Monitor Monitor B105P B155M Patient Monitor Vivid iq 8C-RS 9T-RS M5Sc-RS 3Sc-RS 6Tc-RS 12S-RS ML6-15-RS C1-5-RS 9L-RS P2D 4C-RS 12L-RS L8-18i-RS 6VT-D 6S-RS E8Cs-RS 12L-RS E8C-RS 6S-RS 3Sc-RS Versana Balance 8C-RS E8Cs-RS L6-12-RS 4C-RS LK760-RS RAB2-6-RS 11L-D IC9-D 9L-D C1-5-D RSP6-16-D C1-6-D eM6C G2 RM7C eM6C Voluson E10 RAB2-5-D ML6-15-D C2-9-D RIC6-12-D IC5-9-D Voluson E6 RIC5-9-D Voluson E8 RNA5-9-D M5Sc-D RM6C L2-9-D 3Sc-RS P2D C1-5-RS 6Tc-RS L6-12-RS ML6-15-RS 9L-RS L8-18i-RS 8C-RS 6S-RS Vivid T9 L4-20t-RS M5Sc-RS Vivid T8 E8C-RS 12L-RS 4C-RS 9T-RS Vivid T8 T9 v206 to v208 SW only UPG 12S-RS E8Cs-RS 3Sc-RS IC9B-RS C1-5-RS IC9-RS 12L-RS E8C-RS 4C-RS RAB6-RS Voluson SWIFT RAB2-6-RS Voluson SWIFT+ RIC5-9A-RS Versana Premier E8C-RS 9L-RS 6Tc-RS L6-12-RS 6S-RS 12L-RS L8-18i-RS E8Cs-RS LOGIQ F 3Sc-RS C1-5-RS L3-12-RS E7C8L-RS 8C-RS RIC5-9A-RS 4C-RS L4-20t-RS BE9CS-RS RAB2-6-RS Versana Premier Lotus 12S-RS LK760-RS IC9-RS NG2000 ELITE HEAVY TABLE GT1700V(GT1700V N9 ED3, GT1700V) VT1700V(GT1700V N9 ED3) GT1700V (GT1700V N9 ED3, GT1700V) VT1700 (GT1700 N9 ED3) VT2000X(GT2000x) Lite (LITE TABLE N9 ED3, Lite Table) NG 2000 Table NM/CT Patient Table VT2000 (GT2000 N9 ED3) Kunlun Table NG2000V table G3 RAD Elevation Table Standard table NG1700 Patient Table Table (Model: GCTBL-C4) Table (Model: GCTBL-C33) NG LITE 1700 (NG1700 ELITE STANDARD TABLE) NG2000SV Table NG LITE 2000 (NG2000 ELITE HEAVY TABLE) NG2000SV TABLE NG1700 ELITE STANDARD TABLE Radiographic Table (Model: VFTBL-1) NG1700SV Table Table (Model: GCTBL-C3333) NG1700SV TABLE P2D C1-5-RS 4C-RS 8C-RS L8-18i-RS 9T-RS 6S-RS 3Sc-RS 9L-RS Vivid iq 6Tc-RS L4-20t-RS E8Cs-RS M5Sc-RS 6VT-D Vivid iq v206 to v208 SW only UPG 10T-D 12S-RS ML6-15-RS 12L-RS Vivid iq v206 to v208 HW+SW UPG P2D 9L-D 11L-D 4Vc-D Vivid S70N 6Tc-RS C3-10-D Vivid S60N 3Sc-RS ML6-15-D C1-5-D 6S-D C1-6-D 12S-D 9T-RS 6VT-D Vivid S70N Dimension P6D L8-18i-D IC5-9-D C2-9-D M5Sc-D C1-5-D M5Sc-D 6VT-D 9T-RS Vivid S70N 12S-D P6D 9L-D IC5-9-D C1-6-D L8-18i-D ML6-15-D Vivid S60N 6Tc-RS P2D C2-9-D 6S-D C3-10-D 10T-D 3Sc-RS 11L-D 6S-RS 9T-RS C1-5-RS ML6-15-RS 12L-RS 12S-RS E8Cs-RS P2D 6Tc-RS Vivid T9 4C-RS Vivid T8 L8-18i-RS L6-12-RS 3Sc-RS 8C-RS 9L-RS E8C-RS L4-20t-RS 3Sc-RS Vivid iq 6Tc-RS 6VT-D 12S-RS 9T-RS 6S-RS 8C-RS 4C-RS L8-18i-RS ML6-15-RS 9L-RS 10T-D P2D C1-5-RS M5Sc-RS 12L-RS E8Cs-RS LK760-RS L6-12-RS 3Sc-RS 6S-RS E8C-RS 12L-RS 8C-RS 12S-RS Versana Active RAB2-6-RS 4C-RS 9L-RS L8-18i-RS E8Cs-RS C2-9-D M5Sc-D 9T-RS 6Tc-RS IC5-9-D C3-10-D 6S-D P6D 11L-D 9L-D 3Sc-RS Vivid S60N P2D C1-6-D 6VT-D Vivid S70N 12S-D 10T-D Voluson Performance 18 RAB2-6-RS 9L-RS RAB6-RS 4C-RS 3Sc-RS IC9-RS IC9B-RS RIC5-9A-RS 12L-RS 12S-RS C1-5-RS Voluson Performance 16 C1-6-D RNA5-9-D RAB6-D RIC5-9-D IC9-D Voluson E8 RIC6-12-D IC5-9-D Voluson E10 C4-8-D ML6-15-D eM6C G2 Voluson E6 C2-9-D RAB2-5-D 9L-D RM6C RSP6-16-D eM6C C1-5-D 11L-D eM6CG2 RAB6-D C1-5-D RM6C Voluson E6 IC9-D RAB2-5-D C4-8-D RIC6-12-D 9L-D IC5-9-D Voluson E series BT16 Voluson E8 RSP6-16-D ML6-15-D 11L-D Voluson E6 BT16 Voluson E10 BT16 eM6C RIC5-9-D Voluson E series Voluson E10 Voluson E8 BT16 C1-6-D IC9-D RSP6-16-D eM6C RIC6-12-D 11L-D RAB6-D C2-9-D Voluson E8 RNA5-9-D C1-5-D RIC5-9-D Voluson E6 9L-D ML6-15-D RM6C C4-8-D RAB2-5-D eM6C G2 M5Sc-D Voluson E10 IC5-9-D 3Sc-RS E8C-RS LOGIQ P9 8C-RS ML6-15-RS L8-18i-RS E8CS-RS P6D L10-22-RS 4C-RS L4-12t-RS 12L-RS 6S-RS 9L-RS C1-5-RS RIC5-9A-RS RAB2-6-RS L12n-RS LOGIQ P7 12S-RS L6-12-RS BE9CS-RS L8-18i-D P6D LOGIQ E10 C1-6VN-D C3-10-D RIC5-9-D C1-6-D M5Sc-D 6S-D IC5-9-D 6Tc-RS L2-9VN-D ML6-15-D L2-9-D BE9CS-D RAB6-D P2D C2-9VN-D C2-9-D M5Sc-D 11L-D C2-9-D 6Tc-RS C3-10-D Vivid S70N P2D C1-5-D P6D 6VT-D 9T-RS Vivid S60N IC5-9-D L8-18i-D C1-6-D 10T-D 3Sc-RS 12S-D 9L-D 8C-RS Voluson S6 BT16 RAB6-RS E8C-RS IC9-RS Voluson S10 12L-RS Voluson S series Voluson S8 BT16 Voluson S8 3Sc-RS Voluson S6 9L-RS 12S-RS Voluson S series BT16 Voluson S10 BT16 RIC5-9A-RS ML6-15-RS C1-5-RS 4C-RS LOGIQ e 12L-RS L10-22-RS 8C-RS 9L-RS C1-5-RS L8-18i-RS 6S-RS E8C-RS L4-12t-RS 3Sc-RS RAB2-5-D LOGIQ E9 M6C-D RIC5-9-D RSP6-16-D 3CRF P2D RNA5-9-D L8-18i-D P6D C2-9VN-D 9L-D RAB4-8-D 11L-D C1-6-D IC5-9-D RAB6-D C1-5-D 6S-D C2-9-D LOGIQ E9 XDClear 2 C3-10-D C1-6VN-D S4-10-D E8C-RS C1-5-RS L4-12t-RS Venue Go 8C-RS M5Sc-RS L10-22-RS 12S-RS 12L-RS 3Sc-RS C2-9-RS L8-18i-RS L4-20t-RS 6S-RS ML6-15-RS 6Tc-RS 9L-RS ML6-15-D L4-20t-D BE9CS-D RAB6-D L8-18i-D P2D C2-9VN-D IC5-9-D C1-6VN-D LOGIQ Fortis 6S-D L3-12-D RIC5-9-D 12S-D P6D M5Sc-D 6Tc-RS 9L-D C1-6-D C2-9-D C3-10-D L2-9-D L2-9VN-D 6S-D LOGIQ Totus C1-6VN-D ML6-15-D L6-24-D C1-6-D P2D L4-20t-D M5Sc-D C2-9-D 6Tc-RS P6D IC5-9-D RAB6-D L3-12-D C3-10-D RIC5-9-D Revolution ACT RAB6-D RIC10-D RSP6-16-D RM6C M5Sc-D C2-9-D RIC12-D 9L-D RIC5-9-D L8-18i-D RM7C C1-6-D Voluson Expert 22 Voluson Expert 20 ML6-15-D RIC6-12-D 12S-D IC5-9-D 6S-D 11L-D Voluson Expert 18 eM6C G3 LOGIQ V5 4C-RS L6-12-RS 3Sc-RS RAB2-6-RS 12L-RS LOGIQ V5 Expert E8C-RS E8Cs-RS 8C-RS LOGIQ V3 6S-RS L2-9-D L8-18i-D ML6-15-D 6Tc-RS L2-9VN-D C1-6-D C3-10-D M5Sc-D C2-9-D LOGIQ E10 RAB6-D IC5-9-D RIC5-9-D C2-9VN-D P2D C1-6VN-D 12L-RS E8C-RS 3Sc-RS RIC5-9A-RS RAB2-6-RS 4C-RS Voluson P6 Voluson P8 IC9-RS RIC5-9A-RS 3Sc-RS 12L-RS E8C-RS Voluson P8 IC9-RS Voluson P6 4C-RS IC9B-RS RAB2-6-RS 4C-RS 6S-RS RAB2-6-RS 8C-RS L8-18i-RS E8Cs-RS E8C-RS LOGIQ F8 Expert LOGIQ F6 BE9CS-RS LOGIQ F8 L6-12-RS 3Sc-RS IC5-9-D 9L-D M5Sc-D L8-18i-D Voluson Expert 18 RAB6-D RM7C RIC5-9-D 12S-D RM6C 6S-D RIC6-12-D 11L-D C2-9-D C1-6-D RIC10-D RAB7-D ML6-15-D Voluson Expert 22 RIC12-D RSP6-16-D Voluson Expert 20 eM6C G3 L3-12-D C2-9-D RIC5-9-D L2-9-D P2D ML4-20VN-D L2-9VN-D C1-6-D M5Sc-D LOGIQ E10s ML6-15-D C2-9VN-D 6Tc-RS 6S-D RAB6-D IC5-9-D C3-10-D L4-20t-D ML4-20-D L8-18i-D BE9CS-D C1-6VN-D 12S-D P6D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-01-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-08-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-08-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-08-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-02-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-02-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-02-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-07-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-07-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-11-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-11-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-09-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-09-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-09-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-01-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-01-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-01-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-22
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2022-10-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-10-31
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-10-31
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-04-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-04-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-10-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-11-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-03-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-03-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-03-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-03-26
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-03-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-03-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-03-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-11-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-11-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-07-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-07-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-07-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-04-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-04-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-04-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-09-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-09-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-09-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-05-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-05-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-05-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-09-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-03-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-03-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-03-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-07-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-07-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-07-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-08-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-08-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-08-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-02-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-02-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-02-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-06-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-06-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-09-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-09-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-09-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-10-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-10-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-10-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-09-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-03-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-03-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-03-26
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2022-04-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-04-04
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2022-04-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-04-04
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-04
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2022-04-04
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-04
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-04-04
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-04-04
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-04-04
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-04-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-04-04
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-04-04
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-04-04
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-04-04
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-04-04
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2022-04-04
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2022-04-04
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2022-04-04
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-04-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-04-04
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-04-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-08-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-08-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-08-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-08-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-08-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-08-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-11-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-02-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-02-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-02-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-10-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-10-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-10-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-10-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-10-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-10-25
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	2004-09-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-02-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-02-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-02-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-02-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-02-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-02-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-07-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-07-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-07-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-09-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-09-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-09-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-08-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-08-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-08-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-06-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-06-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-06-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-06-02
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-06-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-06-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-06-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-10-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-10-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-10-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-11-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-10-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-10-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-10-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-02-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-02-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-02-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-04-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-04-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-11-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-02-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-02-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-02-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-02-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-02-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-02-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-01-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-01-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-01-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-06-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-06-27
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-01-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-01-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-01-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-01-08
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-01-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-01-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-01-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-01-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-06-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-11-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-11-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-11-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-08-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-08-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-08-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-01-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-01-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-01-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-04-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-04-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-04-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-02-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-02-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-02-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-03-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-03-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-03-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-12-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-12-23
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-12-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-12-23
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-12-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-12-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-12-03
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

Registration Number	Establishment Name	Location
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
3007233544	VIDA DIAGNOSTICS	Coralville, IA, US
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP
2134213	CANON MEDICAL INFORMATICS, INC.	MINNETONKA, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032109181. Last updated year: 2026. Please use registration number 3032109181 when referencing this establishment in official correspondence.