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EP navigator - 5

by Philips Medical Systems Nederland B.V.

Ref 000071

EP navigator - 5 (000071) is a medical device (EU MDR Class IIb; FDA Class II; EMDN category digital angiography systems - medical device software) made by Philips Medical Systems Nederland B.V., registered in EUDAMED on 24 Oct 2024 (Basic UDI-DI 0884838BM319SW), cleared under FDA 510(k) K142126 on 9 Dec 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00884838059184), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142126

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM319SW Basic UDI-DI 00884838059184UDI-DIDate24 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838059184 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK142126 Date9 Dec 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM319SW registered 24 Oct 2024 Active
  • FDA 510(k) K142126 decided 9 Dec 2014 Active
  • FDA GUDID UDI-DI 00884838059184 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142126
  2. Listed FDA GUDID 00884838059184
  3. Registered EUDAMED 0884838BM319SW

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
EP navigator - 5 EUDAMED
EP navigator GUDID
Generic name
Cardiovascular fluoroscopy/intravascular imaging software
Model / Ref / Catalog
000071, EP navigator - 5
Primary DI / UDI-DI
00884838059184
Basic UDI-DI
0884838BM319SW
FDA product code
OWB, LLZ
EMDN code
Z11030192 Digital angiography systems - medical device software
GMDN term
Cardiovascular fluoroscopy/intravascular imaging software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650, 892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
000071
GUDID
EP navigator - 5
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Angiographic x-ray system application software

Similar devices in this category

Other devices filed under DIGITAL ANGIOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE.

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)