Identity
- Trade Name
- Quantib ND FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Model / Reference
- 2.2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719689791261 FDA UDI
- 510(k) Number
- K213737 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MRI system application software
Quantib ND by Quantib B.V. — 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
- cvi42 — Circle Cardiovascular Imaging · Class II
- MR-RT — Philips Oy · Class II
- RTgo — Philips Oy · Class II
- syngo.MR Spectroscopy — Siemens Healthcare · 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 |
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Manufacturer
- Manufacturer
- Quantib B.V.
Sources (1)
- FDA UDI b6885a81-ce99-4ca8-b76a-3fb571175128 33 fields · synced May 30, 2026