Skip to content

Planmed Clarity

by Planmed Oy

Ref 20009418

Planmed Clarity (20009418) is a device classified as Class IIb in the EU and Class II in the US made by Planmed Oy, registered in EUDAMED on 25 Nov 2021 (Basic UDI-DI B-06430035430079), cleared under FDA 510(k) K163328 on 28 Dec 2017 and listed in FDA GUDID since 26 Nov 2018 (UDI-DI 06430035430079), withdrawn (EUDAMED), active (FDA 510(k)) as of 24 Oct 2026.

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 Withdrawn in European Union.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

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is 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) K163328↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06430035430079 Basic UDI-DI 06430035430079UDI-DIDate25 Nov 2021RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number06430035430079 UDI-DI Date26 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK163328 Date28 Dec 2017IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06430035430079 registered 25 Nov 2021 Withdrawn
  • FDA 510(k) K163328 decided 28 Dec 2017 Active
  • FDA GUDID UDI-DI 06430035430079 listed 26 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163328
  2. Listed FDA GUDID 06430035430079
  3. Registered EUDAMED B-06430035430079

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn

Specification

EUDAMED · 510(k) · GUDID

Trade name
Planmed
Generic name
Stationary mammographic x-ray system, digital
Model / reference
20009418 EUDAMED
Clarity GUDID
Primary DI / UDI-DI
06430035430079
Basic UDI-DI
B-06430035430079
FDA product code
MUE
EMDN code
Z11030202 Digital mammography systems
GMDN term
Stationary mammographic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1715
EU registration type
Legacy device (under a directive)
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
20009418
GUDID
Clarity
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.

Manufacturer details

EUDAMED SRN
FI-MF-000006837

Similar devices in this category

Other devices filed under DIGITAL MAMMOGRAPHY SYSTEMS.

Other devices from Planmed Oy

See all devices from Planmed Oy →

Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)