Na 6265300-22

by GE Medical Systems, L.L.C.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00195278596642 UDI-DI	Date23 Aug 2022Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Full-body MRI system, superconducting magnet
Model / Reference: 6265300-22

Primary DI / UDI-DI: 00195278596642
FDA Product Code: KXJ
GMDN Term: Full-body MRI system, superconducting magnet

Device Class: Class II
Regulation Number: 892.1980
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Premarket Exempt
Serial Number

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Expiration Date: No
Manufacturing Date: No