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FireCR Spark FR31

by Digiray Corp.

Ref FireCR Spark

FireCR Spark FR31 (CG-301) is a device classified as Class IIa in the EU and Class II in the US made by Digiray Corp., registered in EUDAMED on 12 Jun 2026 (Basic UDI-DI 08809466040313S), cleared under FDA 510(k) K133120 on 15 Jan 2014 and listed in FDA GUDID since 27 Oct 2016 (UDI-DI 08809466040313), 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) K133120

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 Number08809466040313S Basic UDI-DI 08809466040313UDI-DIDate12 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809466040313 UDI-DI Date27 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK133120 Date15 Jan 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08809466040313S registered 12 Jun 2026 Active
  • FDA 510(k) K133120 decided 15 Jan 2014 Active
  • FDA GUDID UDI-DI 08809466040313 listed 27 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K133120
  2. Listed FDA GUDID 08809466040313
  3. Registered EUDAMED 08809466040313S

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  • Withdrawn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
FireCR Spark
Generic name
Computed radiography digital imaging scanner
Model / Ref / Catalog
FireCR Spark EUDAMED
FR31 GUDID
CG-301 GUDID
Primary DI / UDI-DI
08809466040313
Basic UDI-DI
08809466040313S
510(k) Number
FDA product code
MQB
EMDN code
Z11060201 Single-input computed radiography (cr) systems
GMDN term
Computed radiography digital imaging scanner
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1680
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Weight — 21.5 Kilogram
Width — 44.4 Centimeter
Length — 79.5 Centimeter
Height — 13.4 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FireCR Spark
GUDID
FR31
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: Computed radiography digital imaging scanner

Cleared under the same submission (K133120)

and 1 more cleared under K133120

Similar devices in this category

Other devices filed under SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS.

Other devices from Digiray Corp.

See all devices from Digiray Corp. →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)