EXACT IMAGING, INC.

FDA Device Registration & Listing · Markham Ontario, CA · Registration 3012402886

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012402886
FEI Number
3012402886
Entity Name
EXACT IMAGING, INC.
City/State/Country
Markham Ontario, CA
Establishment Address
7676 Woodbine Avenue, Unit 15, Markham Ontario L3R 2N2, CA
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Exact Imaging, Inc. (Owner Number: 10053728)
Owner / Operator Contact Address
7676 Woodbine Avenue, Unit 15, Markham, CA-ON L3R 2N2, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K162972
PMA Number
N/A

All Registered Proprietary Names

SHEATHES (NON-LATEX), STERILE Transperineal Transducer Cradle Transperineal Reusable Template Transperineal Stepper Transperineal Disposable Template EV29L Sterile Transperineal Needle Guide EV29L Sterile Transperineal Needle Guide Kit EV5C Abdominal Transducer EV29L High Resolution Side-Fire Transducer ExactVu High Resolution Micro-Ultrasound System EV9C Transrectal End-Fire Transducer EV29L Sterile Transrectal Needle Guide Kit EV29L Sterile Transrectal Needle Guide EV29L Reusable Transrectal Needle Guide (16 & 18 GA) EV29L Sterile Biopsy Needle Guide EV29L High Resolution Transrectal Side-Fire Transducer EV29L Reusable Needle Guide ExactVu™ High Resolution Micro-Ultrasound System EV9C Transrectal End-Fire Transducer ExactVu™ High Resolution Micro-Ultrasound System EV9C Transrectal End-Fire Transducer EV29L High Resolution Transrectal Side-Fire transducer EV29L Sterile Biopsy Needle Guide

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-04-26
IWJ System, Applicator, Radionuclide, Manual Radiology Class 1 892.5650 2019-06-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2019-10-07
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2019-10-07
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-10-07
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2019-10-07
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2018-05-07
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-05-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-05-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-01-05
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-01-05
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2017-01-05

Official Correspondent

Randy AuCoin

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Exact Imaging, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13
K973037 Avid N.I.T., Inc. N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 1998-01-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0040-2012 Worldwide Medical Technologies, LLC 1
Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012402886. Last updated year: 2026. Please use registration number 3012402886 when referencing this establishment in official correspondence.
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