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myray hyperion X5 (3D CEPH)

by Cefla Societa' Cooperativa

Part of a family of 34 devices: see the family page

Ref 70BB0000, 70B1B000Model Panoramic, cephalometric and tomographic X-ray equipment

myray hyperion X5 (3D CEPH) (70BB0000) is a device classified as Class IIb in the EU and Class II in the US made by Cefla Societa' Cooperativa, registered in EUDAMED on 13 Nov 2025 (Basic UDI-DI 803383793IMXRAYEXB001SY), cleared under FDA 510(k) K200688 on 9 Apr 2020 and listed in FDA GUDID since 4 May 2020 (UDI-DI 08033837932888), 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) K200688

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 Number803383793IMXRAYEXB001SY Basic UDI-DI 08033837932888UDI-DIDate13 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08033837932888 UDI-DI Date4 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK200688 Date9 Apr 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803383793IMXRAYEXB001SY registered 13 Nov 2025 Active
  • FDA 510(k) K200688 decided 9 Apr 2020 Active
  • FDA GUDID UDI-DI 08033837932888 listed 4 May 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200688
  2. Listed FDA GUDID 08033837932888
  3. Registered EUDAMED 803383793IMXRAYEXB001SY

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  • Withdrawn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
hyperion X5 EUDAMED
myray GUDID
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
Panoramic, cephalometric and tomographic X-ray equipment, 70BB0000, 70B1B000, hyperion X5 (3D CEPH)
Primary DI / UDI-DI
08033837932888
Basic UDI-DI
803383793IMXRAYEXB001SY
Direct marketing DI
08033837932888
510(k) Number
FDA product code
MUH, OAS
EMDN code
Z1103030102 Equipment for extraoral dental radiology, digital
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.1800, 892.1750
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Panoramic, cephalometric and tomographic X-ray equipment
70BB0000, 70B1B000
GUDID
hyperion X5 (3D CEPH)
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Stationary panoramic/tomographic dental x-ray system, digital

Similar devices in this category

Other devices filed under EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL.

Other devices from Cefla Societa' Cooperativa

See all devices from Cefla Societa' Cooperativa →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)