Skip to content

FloNavi Image Processing Unit

by Guangdong Optomedic Technologies, Inc. 2 variants

Ref OPTO-CAM214KModel OPTO-CAM214K,71-068-05 NIR,71-068-05 NIR-CA

FloNavi Image Processing Unit (OPTO-CAM214K) is a medical device (EU MDR Class I; FDA Class II; EMDN category video processors) made by Guangdong Optomedic Technologies, Inc., registered in EUDAMED on 21 Mar 2023 (Basic UDI-DI 697303129CAM0000298), cleared under FDA 510(k) K221861 on 18 Feb 2023 and listed in FDA GUDID since 14 Nov 2023 (UDI-DI 06973031299955), 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) K221861

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06973031299955 UDI-DI Date14 Nov 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697303129CAM0000298 Basic UDI-DI 06973031299955UDI-DIDate21 Mar 2023RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK221861 Date18 Feb 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697303129CAM0000298 registered 21 Mar 2023 Active
  • FDA 510(k) K221861 decided 18 Feb 2023 Active
  • FDA GUDID UDI-DI 06973031299955 listed 14 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K221861
  2. Registered EUDAMED 697303129CAM0000298
  3. Listed FDA GUDID 06973031299955

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  • Withdrawn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
FloNavi Image Processing Unit EUDAMED
Image Processing Unit GUDID
Generic name
Stationary general-purpose fluoroscopic x-ray system, digital
Model / reference
OPTO-CAM214K, 71-068-05 NIR, 71-068-05 NIR-CA
Primary DI / UDI-DI
06973031299955
Basic UDI-DI
697303129CAM0000298
510(k) Number
FDA product code
GCJ, IZI
EMDN code
Z12020406 Video processors
GMDN term
Stationary general-purpose fluoroscopic x-ray system, digital
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500, 892.1600
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
CN-MF-000011588
Authorised representative
Share info GmbH DE-AR-000005132

Similar devices in this category

Other devices filed under VIDEO PROCESSORS.

Other devices from Guangdong Optomedic Technologies, Inc.

See all devices from Guangdong Optomedic Technologies, Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)