Identity
- Trade Name
- iQMR FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI images. The image processing provide enhanced quality by reducing the image noise level. FDA UDI
- Model / Reference
- 1.2 FDA UDI
- Description
- The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI images. The image processing provide enhanced quality by reducing the image noise level. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016836400 FDA UDI
- 510(k) Number
- K173605 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
No
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
Yes
FDA UDI
Category: MRI system application software
iQMR by Medic Vision Imaging Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI system application software.
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- 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
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
- Medic Vision Imaging Solutions
Sources (1)
- FDA UDI 65146918-0678-409f-b690-d23f8c1119ac 34 fields · synced May 30, 2026