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INTRABEAM SMART Stand 6650

by Carl Zeiss Meditec AG

Ref 6650

INTRABEAM SMART Stand 6650 is a medical device (EU MDR Class I; FDA Class II; FDA product code JAD, System, Therapeutic, X-Ray; EMDN category general medicine instruments) made by Carl Zeiss Meditec AG, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 4049539_0_6650_U3), cleared under FDA 510(k) K241174 on 10 Jan 2025 and listed in FDA GUDID since 1 Apr 2025 (UDI-DI 04049539066503), 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) K241174

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 Number4049539_0_6650_U3 Basic UDI-DI 04049539066503UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049539066503 UDI-DI Date1 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241174 Date10 Jan 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4049539_0_6650_U3 registered 23 Jul 2026 Active
  • FDA 510(k) K241174 decided 10 Jan 2025 Active
  • FDA GUDID UDI-DI 04049539066503 listed 1 Apr 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241174
  2. Listed FDA GUDID 04049539066503
  3. Registered EUDAMED 4049539_0_6650_U3

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  • Withdrawn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
INTRABEAM SMART Stand
Generic name
Intraoperative/postoperative therapeutic x-ray system
Model / reference
6650
Primary DI / UDI-DI
04049539066503
Basic UDI-DI
4049539_0_6650_U3
Direct marketing DI
04049539066503
510(k) Number
FDA product code
JAD
EMDN code
Z120499 General medicine instruments - other
GMDN term
Intraoperative/postoperative therapeutic x-ray system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5900
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 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: Intraoperative/postoperative therapeutic x-ray system

Cleared under the same submission (K241174)

and 5 more cleared under K241174

Similar devices in this category

Other devices filed under GENERAL MEDICINE INSTRUMENTS - OTHER.

Other devices from Carl Zeiss Meditec AG

See all devices from Carl Zeiss Meditec AG →

Properties

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