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Scanmate B DGH 8000

by Dgh Technology Inc.

Ref DGH 8000

Scanmate B DGH 8000 is a device classified as Class IIa in the EU and Class II in the US made by Dgh Technology Inc., registered in EUDAMED on 18 Aug 2023 (Basic UDI-DI B-00857377006100), cleared under FDA 510(k) K070907 on 17 Apr 2007 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00857377006100), withdrawn (EUDAMED), active (FDA 510(k)) as of 22 Oct 2026.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US).

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is 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) K070907

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/MDD EUDAMED NumberB-00857377006100 Basic UDI-DI 00857377006100UDI-DIDate18 Aug 2023RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00857377006100 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK070907 Date17 Apr 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00857377006100 registered 18 Aug 2023 Withdrawn
  • FDA 510(k) K070907 decided 17 Apr 2007 Active
  • FDA GUDID UDI-DI 00857377006100 listed 11 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K070907
  2. Listed FDA GUDID 00857377006100
  3. Registered EUDAMED B-00857377006100

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Scanmate B
Generic name
Ophthalmic ultrasound imaging transducer
Model / reference
DGH 8000
Primary DI / UDI-DI
00857377006100
Basic UDI-DI
B-00857377006100
510(k) Number
FDA product code
ITX, IYO
EMDN code
Z11040199 Ultrasound scanners - other
GMDN term
Ophthalmic ultrasound imaging transducer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570, 892.1560
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Ophthalmic ultrasound imaging systemOphthalmic ultrasound imaging transducer

Similar devices in this category

Other devices filed under ULTRASOUND SCANNERS - OTHER.

Other devices from Dgh Technology Inc.

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Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (20, all answered No)