Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026047529

FEI Number

3026047529

Entity Name

20MED PTE LTD

City/State/Country

Singapore Central Singapore, SG

Establishment Address

#09-01, 20 Collyer Quay, Singapore Central Singapore 049319, SG

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

20MED PTE LTD (Owner Number: 10087046)

Owner / Operator Contact Address

#09-01, 20 Collyer Quay, Singapore, SG-01 049319, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173079

PMA Number

N/A

All Registered Proprietary Names

20MED PET1 20MED CT4 20MED MR4 20MED USG1 20MED MR3 20MED CT3 20MED MR1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2026-03-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-01-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-19
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-06-06
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2023-06-06
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-06-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-01-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-01-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-01-05
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-03-04
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-03-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-03-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-01-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-08-26
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-08-26

Official Correspondent

PIYUSH SETH

US Agent Details

Emily Matorin Business: FDABASICS LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

20MED PTE LTD

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
K033956	Is2 Research, Inc.	MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)	2004-01-20
K923309	GE Medical Systems	ARGUS PET SYSTEM	1992-09-29
K101768	Miegmbh	MIE SCINTRON GAMMA CAMERA SYSTEMS	2010-10-05
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0392-2024	Philips North America Llc	2	Ingenia 1.5T CX
Z-0393-2024	Philips North America Llc	2	Intera 1.5T
Z-0005-2016	Toshiba American Medical Systems Inc	2	Celesteion PCA-9000A/2 PET/CT System

Similar Registrations

Registration Number	Establishment Name	Location
3032577207	POSITRIGO AG	Zurich, CH
3009136051	CEDARS SINAI MEDICAL CENTER	Los Angeles, CA, US
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3011950073	United Imaging Healthcare North America, Inc	Houston, TX, US
3008962177	GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.	Valencia, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026047529. Last updated year: 2026. Please use registration number 3026047529 when referencing this establishment in official correspondence.