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eRAD PACS Evolution 8.0

by Erad, Inc.

Ref eRAD PACS

eRAD PACS Evolution 8.0 is a device classified as Class IIa in the EU and Class II in the US made by Erad, Inc., registered in EUDAMED on 18 Jun 2025 (Basic UDI-DI 08669940002246A), cleared under FDA 510(k) K120995 on 3 Dec 2012 and listed in FDA GUDID since 1 Jun 2016 (UDI-DI 00866994000224), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120995

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08669940002246A Basic UDI-DI 00866994000224UDI-DIDate18 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00866994000224 UDI-DI Date1 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK120995 Date3 Dec 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08669940002246A registered 18 Jun 2025 Active
  • FDA 510(k) K120995 decided 3 Dec 2012 Active
  • FDA GUDID UDI-DI 00866994000224 listed 1 Jun 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120995
  2. Listed FDA GUDID 00866994000224
  3. Registered EUDAMED 08669940002246A

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  • Withdrawn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
eRAD PACS EUDAMED
eRAD PACS Evolution GUDID
Generic name
Radiological PACS-dedicated management software
Model / reference
eRAD PACS EUDAMED
8.0 GUDID
Primary DI / UDI-DI
00866994000224
Basic UDI-DI
08669940002246A
Direct marketing DI
00866994000224
510(k) Number
FDA product code
LLZ
EMDN code
Z110603 Picture archiving and communication systems
GMDN term
Radiological PACS-dedicated management software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
eRAD PACS
GUDID
8.0
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Radiological PACS software

Cleared under the same submission (K120995)

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from Erad, Inc.

See all devices from Erad, Inc. →

Properties

  • Serial number
Other properties (24, all answered No)