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1.5T HD T/R QUADEXTREMITY COIL (flat base)

by Philips Medical Systems Nederland B.V.

Ref 300007306031510(k) K222257

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222257↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM915TL Basic UDI-DI 00884838108844UDI-DIDate16 Jan 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK222257 Date23 Aug 2022ClearedStatusActive
United StatesGUDID listing GUDID Number00884838108844 UDI-DI Date31 Mar 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
1.5T HD T/R QUADEXTREMITY COIL (flat base) EUDAMED
Dunlee Sentinelle GUDID
Generic Name
MRI system coil, radio-frequency
Device Name
GE TxRx Coil PMS
Model / Ref / Catalog
300007306031, 1.5T HD T/R QUAD EXTREMITY COIL (flat base)
Primary DI / UDI-DI
00884838108844
Basic UDI-DI
0884838BM915TL
Direct Marketing DI
00884838108844
FDA Product Code
MOS
EMDN Code
Z1105018001, Z1105018002, Z1105018099
GMDN Term
MRI system coil, radio-frequency
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1000
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
300007306031
GUDID
1.5T HD T/R QUAD EXTREMITY COIL (flat base)
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489
FDA applicant
Invivo Corporation (Business Trade Name: Philips)

Other devices from Philips Medical Systems Nederland B.V.

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Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No