Identity
- Trade Name
- AlignRT Plus FDA UDI
- Generic Name
- Radiological video camera patient positioning/tracking system FDA UDI
- Model / Reference
- Workstation Z4 - OSMS TB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056190500191 FDA UDI
- 510(k) Number
- K203387 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological video camera patient positioning/tracking system 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
Yes
FDA UDI
Category: Radiological video camera patient positioning/tracking system
AlignRT Plus by Vision RT Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological video camera patient positioning/tracking system.
- LUNA 3D — L A P GMBH LASER APPLIKATIONEN · Class II
- TCL3 Motion Tracking System — Tracinnovations A/S · Class II
- LUNA 3D — L A P GMBH LASER APPLIKATIONEN · Class II
- AlignRT Plus — Vision RT Limited · Class II
- AlignRT Plus — Vision RT Limited · Class II
- AlignRT Plus — Vision RT Limited · Class II
- AlignRT Plus — Vision RT Limited · Class II
- AlignRT Plus — Vision RT Limited · Class II
Cleared under the same submission
K203387 also covers:
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
- AlignRT Plus — Vision RT Limited
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
- Vision RT Limited
Sources (1)
- FDA UDI 35b1b75a-2ce4-443e-b9eb-b0e5acbec057 34 fields · synced Jun 8, 2026