Identity
- Trade Name
- TruPlan EUDAMEDFDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- TruPlan EUDAMED
- Model / Reference
- v3.x EUDAMED3.x FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00882916000530 EUDAMEDFDA UDI
- Basic UDI-DI
- 882916TRP68 EUDAMED
- Direct Marketing DI
- 00882916000530 EUDAMED
- 510(k) Number
- K222593 FDA UDI
- FDA Product Code
- QIH FDA UDILLZ FDA UDI
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full-body CT system
TruPlan by Circle Cardiovascular Imaging Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202212 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 882916TRP68 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Circle Cardiovascular Imaging Inc
- EUDAMED SRN
- CA-MF-000011835
- FDA Applicant
- Circle Cardiovascular Imaging, Inc.
- Authorised Representative
- QDossier B.V. NL-AR-000033747
Sources (3)
- EUDAMED 29f2953a-4c6c-4987-93dd-cbd1fe1e761e 85 fields · synced Jun 18, 2026
- FDA UDI d7f190c0-da8d-4805-bb8a-8e57f70a12ee 33 fields · synced May 29, 2026
- FDA 510(k) K202212 1 fields · synced May 18, 2026