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HOLOSCOPE-i

by Real View Imaging, Ltd.

Ref SYS000002Model HOLOSCOPE-i

HOLOSCOPE-i is an ultrasound imaging system workstation (EU MDR Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Real View Imaging, Ltd., registered in EUDAMED on 11 May 2026 (Basic UDI-DI 729001886201CR), cleared under FDA 510(k) K210072 on 14 May 2021 and listed in FDA GUDID since 1 Nov 2021 (UDI-DI 07290018862018), 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) K210072

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 Number729001886201CR Basic UDI-DI 07290018862018UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290018862018 UDI-DI Date1 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210072 Date14 May 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729001886201CR registered 11 May 2026 Active
  • FDA 510(k) K210072 decided 14 May 2021 Active
  • FDA GUDID UDI-DI 07290018862018 listed 1 Nov 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K210072
  2. Listed FDA GUDID 07290018862018
  3. Registered EUDAMED 729001886201CR

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  • Withdrawn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
HOLOSCOPE-i EUDAMED
Holoscope GUDID
Generic name
Ultrasound imaging system workstation
Model / reference
HOLOSCOPE-i, SYS000002
Primary DI / UDI-DI
07290018862018
Basic UDI-DI
729001886201CR
Direct marketing DI
07290018862018
510(k) Number
FDA product code
LLZ
EMDN code
Z11069099 Various digital bioimaging management instruments - other
GMDN term
Ultrasound imaging system workstation
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
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: Ultrasound imaging system workstationCT system workstation

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER.

Other devices from Real View Imaging, Ltd.

  • HOLOSCOPE-i

    Class II

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)