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Pedra 1417MC

by Radisen Co., Ltd.

Ref PEDRA-1417MC

Pedra 1417MC (PEDRA-1417MC) 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 8 Jul 2026 (Basic UDI-DI B-08800099500083), cleared under FDA 510(k) K221144 on 13 May 2022 and listed in FDA GUDID since 15 Nov 2023 (UDI-DI 08800099500083), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221144

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800099500083 Basic UDI-DI 08800099500083UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800099500083 UDI-DI Date15 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK221144 Date13 May 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800099500083 registered 8 Jul 2026 Active
  • FDA 510(k) K221144 decided 13 May 2022 Active
  • FDA GUDID UDI-DI 08800099500083 listed 15 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K221144
  2. Listed FDA GUDID 08800099500083
  3. Registered EUDAMED B-08800099500083

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  • Withdrawn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-1417MC EUDAMED
Pedra GUDID
Generic name
Indirect flat panel x-ray detector
Device name
Digital Flat Panel Detector
Model / Ref / Catalog
PEDRA-1417MC, 1417MC
Primary DI / UDI-DI
08800099500083
Basic UDI-DI
B-08800099500083
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-1417MC
GUDID
1417MC
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 (K221144)

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 17FC

    Class II

  • Pedra 17F

    Class II

  • Pedra 17FG

    Class II

See all devices from Radisen Co., Ltd. →

Properties

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