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Discovery RF180

by General Medical Merate SpA

Part of a family of 7 devices: see the family page

Ref DISCOVERY RF180Model RF rooms

Discovery RF180 is a device classified as Class IIb in the EU and Class II in the US made by General Medical Merate SpA, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI 805489048SRFRD), cleared under FDA 510(k) K213081 on 26 Oct 2021 and listed in FDA GUDID since 11 Jul 2018 (UDI-DI 08054890480109), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213081

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805489048SRFRD Basic UDI-DI 08054890480109UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213081 Date26 Oct 2021DecidedStatusActive
United StatesGUDID listing GUDID Number08054890480109 UDI-DI Date11 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805489048SRFRD registered 26 Jun 2026 Active
  • FDA 510(k) K213081 decided 26 Oct 2021 Active
  • FDA GUDID UDI-DI 08054890480109 listed 11 Jul 2018 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 08054890480109
  2. Cleared FDA 510(k) K213081
  3. Registered EUDAMED 805489048SRFRD

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  • Withdrawn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

Generic name
Stationary general-purpose fluoroscopic x-ray system, digital
Device name
RF rooms
Model / reference
Discovery RF180, RF rooms
Primary DI / UDI-DI
08054890480109
Basic UDI-DI
805489048SRFRD
510(k) Number
FDA product code
KXJ, MQB, IZI, JAA, IZF
EMDN code
Z11039009 Fluoroscopy devices
GMDN term
Stationary general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1980, 892.1680, 892.1600, 892.1650, 892.1740
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 general-purpose fluoroscopic x-ray system, digital

Cleared under the same submission (K213081)

and 6 more cleared under K213081

Similar devices in this category

Other devices filed under FLUOROSCOPY DEVICES.

Other devices from General Medical Merate SpA

See all devices from General Medical Merate SpA →

Properties

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