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Alta RT-4800-02

by Qfix

Part of a family of 59 devices: see the family page

Ref RT-4800-02Model Couchtops, Overlays, and Multipurpose Devices

Alta RT-4800-02 is a device classified as Class I in the EU and Class II in the US made by Qfix, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 8419621COUCHTOPSMPD6F), cleared under FDA 510(k) K193243 on 28 Feb 2020 and listed in FDA GUDID since 9 Jul 2025 (UDI-DI 00841962119603), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193243

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/MDR EUDAMED Number8419621COUCHTOPSMPD6F Basic UDI-DI 00841962119603UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841962119603 UDI-DI Date9 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193243 Date28 Feb 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8419621COUCHTOPSMPD6F registered 22 May 2026 Active
  • FDA 510(k) K193243 decided 28 Feb 2020 Active
  • FDA GUDID UDI-DI 00841962119603 listed 9 Jul 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193243
  2. Listed FDA GUDID 00841962119603
  3. Registered EUDAMED 8419621COUCHTOPSMPD6F

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  • Withdrawn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
Alta
Generic name
Indexed-immobilization patient positioning system
Model / Ref / Catalog
RT-4800-02, Couchtops, Overlays, and Multipurpose Devices
Primary DI / UDI-DI
00841962119603
Basic UDI-DI
8419621COUCHTOPSMPD6F
510(k) Number
FDA product code
FRZ, IYE, JAI, JAK, KPS, LHN, LNH, OUO
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Indexed-immobilization patient positioning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6775, 892.5050, 892.5770, 892.1750, 892.1200, 892.1000
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

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: Indexed-immobilization patient positioning system

Cleared under the same submission (K193243)

and 3 more cleared under K193243

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from Qfix

See all devices from Qfix →

Properties

  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)