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Pedra 17FC

by Radisen Co., Ltd.

Ref RS-AD-170912-01Model PEDRA-17FC

Pedra 17FC (PEDRA-17FC) is a device classified as Class IIb in the EU and Class II in the US made by Radisen Co., Ltd., registered in EUDAMED on 23 Oct 2023 (Basic UDI-DI B-08800099500052), cleared under FDA 510(k) K180989 on 13 Jun 2018 and listed in FDA GUDID since 15 Nov 2023 (UDI-DI 08800099500052), active as of 23 Oct 2026.

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

CE MDD 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) K180989

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800099500052 UDI-DI Date15 Nov 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08800099500052 Basic UDI-DI 08800099500052UDI-DIDate23 Oct 2023RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180989 Date13 Jun 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800099500052 registered 23 Oct 2023 Active
  • FDA 510(k) K180989 decided 13 Jun 2018 Active
  • FDA GUDID UDI-DI 08800099500052 listed 15 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180989
  2. Registered EUDAMED B-08800099500052
  3. Listed FDA GUDID 08800099500052

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Pedra-17F EUDAMED
Pedra GUDID
Generic name
Indirect flat panel x-ray detector
Device name
Digital Flat Panel X-Ray Detector
Model / Ref / Catalog
PEDRA-17FC, RS-AD-170912-01, 17FC
Primary DI / UDI-DI
08800099500052
Basic UDI-DI
B-08800099500052
510(k) Number
FDA product code
MQB
EMDN code
Z11031180 Systems for direct digital radiology (dr) - hardware accessories
GMDN term
Indirect flat panel x-ray detector
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1680
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PEDRA-17FC
RS-AD-170912-01
GUDID
17FC
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: Indirect flat panel x-ray detector

Cleared under the same submission (K180989)

Similar devices in this category

Other devices filed under SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES.

Other devices from Radisen Co., Ltd.

  • Axir-Cx

    Class II

  • Pedra 17F

    Class II

  • Pedra 17FG

    Class II

  • Pedra 1417mg

    Class II

See all devices from Radisen Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)