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Canon Inc. Cx-1

by Canon Inc.

Ref BT8-1757Model Digital Retinal Camera

Canon Inc. Cx-1 is a device classified as Class I in the EU and Class II in the US made by Canon Inc., registered in EUDAMED on 5 Sep 2023 (Basic UDI-DI 4549292rc01DK), cleared under FDA 510(k) K092565 on 18 Mar 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04549292074345), 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) K092565

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 Number4549292rc01DK Basic UDI-DI 04549292074345UDI-DIDate5 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number04549292074345 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK092565 Date18 Mar 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4549292rc01DK registered 5 Sep 2023 Active
  • FDA 510(k) K092565 decided 18 Mar 2010 Active
  • FDA GUDID UDI-DI 04549292074345 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K092565
  2. Listed FDA GUDID 04549292074345
  3. Registered EUDAMED 4549292rc01DK

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  • Withdrawn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
Digital Retinal Camera CX-1 EUDAMED
Canon Inc. GUDID
Generic name
Ophthalmic fundus camera
Device name
Cr-10
Model / reference
Digital Retinal Camera EUDAMED
BT8-1757 EUDAMED
CX-1 GUDID
Primary DI / UDI-DI
04549292074345
Basic UDI-DI
4549292rc01DK
510(k) Number
FDA product code
HKI, NFJ
EMDN code
Z12120114 Ophthalmoscopes
GMDN term
Ophthalmic fundus camera
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.1120, 892.2050
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
Digital Retinal Camera
BT8-1757
GUDID
CX-1
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.

Related devices

Category: Ophthalmic fundus camera

Similar devices in this category

Other devices filed under OPHTHALMOSCOPES.

Other devices from Canon Inc.

See all devices from Canon Inc. →

Properties

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