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TruPlan

by Circle Cardiovascular Imaging Inc 2 variants

Ref v3.x

TruPlan (v3.x) is a device classified as Class IIa in the EU and Class II in the US made by Circle Cardiovascular Imaging, cleared under FDA 510(k) K222593 on 18 Jan 2023 (1 earlier submission), registered in EUDAMED on 27 Sep 2022 (Basic UDI-DI 882916TRP68) and listed in FDA GUDID since 23 Jan 2023 (UDI-DI 00882916000530), 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) K222593

+1 more

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00882916000530 UDI-DI Date23 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222593 Date18 Jan 2023DecidedStatusActive
European UnionCE/MDR EUDAMED Number882916TRP68 Basic UDI-DI 00882916000530UDI-DIDate27 Sep 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK202212 Date19 Feb 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K222593 decided 18 Jan 2023 Active· +1 more in the status table
  • EUDAMED Basic UDI-DI 882916TRP68 registered 27 Sep 2022 Active
  • FDA GUDID UDI-DI 00882916000530 listed 23 Jan 2023 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K202212
  2. Registered EUDAMED 882916TRP68
  3. Cleared FDA 510(k) K222593
  4. Listed FDA GUDID 00882916000530

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
CT system application software
Model / reference
v3.x EUDAMED
3.x GUDID
Primary DI / UDI-DI
00882916000530
Basic UDI-DI
882916TRP68
Direct marketing DI
00882916000530
510(k) Number
FDA product code
QIH, LLZ
EMDN code
Z11030682 Computed tomographs (CT) - software accessories
GMDN term
CT system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
v3.x
GUDID
3.x
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
CA-MF-000011835
Authorised representative
QDossier B.V. NL-AR-000033747

Related devices

Category: Full-body CT system

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES.

Other devices from Circle Cardiovascular Imaging

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Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)