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AV Viewer

by Philips Medical Systems Nederland B.V.

Ref 989780000042Model AV Viewer

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

CE MDR 510(k)

Valid until

1 Jul 2030

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K250181↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00884838129917 UDI-DI Date23 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number2243163CE01 Date20 Jan 2026IssuedStatusActive expires 1 Jul 2030
United StatesFDA 510(k) 510(k) NumberK250181 Date15 Jul 2025IssuedStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243163CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    20 Jan 2026
    Expires
    1 Jul 2030
    Reason
    Add device or group

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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 · 510(k) · GUDID

Trade Name
AV Viewer EUDAMED
AV Viewer V1 GUDID
Generic Name
Radiology DICOM image processing application software
Model / Ref / Catalog
AV Viewer, 989780000042, 1
Primary DI / UDI-DI
00884838129917
Basic UDI-DI
0884838BM1871N8
Direct Marketing DI
00884838129917
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z11069082 Various digital bioimaging management instruments - software accessories
GMDN Term
Radiology DICOM image processing application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AV Viewer
989780000042
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

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

Properties

  • Measuring Function
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No