Identity
- Trade Name
- RTgo FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- MR-RT RTgo software USB stick FDA UDI
- Model / Reference
- 989603083082 FDA UDI
- Description
- MR-RT RTgo software USB stick FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838084667 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- GMDN Term
- MRI system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
MR Safe FDA UDI
Category: MRI system application software
RTgo by Philips Oy — 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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- syngo.MR Cardiology — Siemens Healthcare · Class II
- Quantib ND — Quantib B.V. · 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
- Philips Oy
Sources (1)
- FDA UDI 5426694d-1725-4574-ac66-2c6d89ec6612 34 fields · synced May 29, 2026