Identity
- Trade Name
- cvi42 FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Model / Reference
- 5.x FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00882916000011 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- MRI system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MRI system application software
cvi42 by Circle Cardiovascular Imaging — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI system application software.
- syngo.MR Vascular — Siemens Healthcare · Class II
- nordicMEDIVA — Nordicneurolab · Class II
- MR-RT — Philips Oy · Class II
- RTgo — Philips Oy · Class II
- syngo.MR Spectroscopy — Siemens Healthcare · Class II
- Quantib ND — Quantib B.V. · Class II
- FerriScan, Cardiac T2* — Resonance Health Analysis Services Pty, Ltd. · Class II
- syngo.MR Cardiology — Siemens Healthcare · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Circle Cardiovascular Imaging
Sources (1)
- FDA UDI ec8831be-700c-4469-bbd8-16d79565f1da 33 fields · synced May 30, 2026