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EmboGuide - 1

by Philips Medical Systems Nederland B.V.

Ref 001012

EmboGuide - 1 (001012) 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 25 Sep 2024 (Basic UDI-DI 0884838BM316SQ), cleared under FDA 510(k) K142273 on 30 Jan 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00884838059290), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142273

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM316SQ Basic UDI-DI 00884838059290UDI-DIDate25 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838059290 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142273 Date30 Jan 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM316SQ registered 25 Sep 2024 Active
  • FDA 510(k) K142273 decided 30 Jan 2015 Active
  • FDA GUDID UDI-DI 00884838059290 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142273
  2. Listed FDA GUDID 00884838059290
  3. Registered EUDAMED 0884838BM316SQ

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  • Withdrawn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
EmboGuide
Generic name
Cardiovascular fluoroscopy/intravascular imaging software
Model / Ref / Catalog
001012, EmboGuide - 1
Primary DI / UDI-DI
00884838059290
Basic UDI-DI
0884838BM316SQ
FDA product code
OWB, LLZ, JAK
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, 892.1750
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
001012
GUDID
EmboGuide - 1
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

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)