Identity
- Trade Name
- AlignRT Plus FDA UDI
- Generic Name
- Radiological video camera patient positioning/tracking system FDA UDI
- Model / Reference
- GateCT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056190500023 FDA UDI
- 510(k) Number
- K123371 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_510K — listed in FDA GUDID, FDA 510(k) — 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
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123371 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K052682 | Class II | Active |
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Manufacturer
- Manufacturer
- Vision RT Limited
Sources (2)
- FDA UDI 60e22fe2-62fd-4a3e-b437-9bf363cb5efd 58 fields · synced Jun 19, 2026
- FDA 510(k) K123371 1 fields · synced Jun 9, 2026