Identity
- Trade Name
- Respiratory Gating for Scanners (RGSC) FDA UDI
- Generic Name
- Real-time position management respiratory gating system, optical FDA UDI
- Device Name
- RGSC FDA UDI
- Model / Reference
- 1.1 FDA UDI
- Description
- RGSC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856100006028 FDA UDI
- 510(k) Number
- K151533 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Real-time position management respiratory gating system, optical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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: Real-time position management respiratory gating system, optical
Respiratory Gating for Scanners (RGSC) by Varian Medical Systems Imaging Laboratory GmbH — Class II — FDA UDI — listed in FDA GUDID
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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
- Varian Medical Systems Imaging Laboratory GmbH
Sources (1)
- FDA UDI 440f823b-8e49-43a5-aed6-98c36bcbc85a 34 fields · synced Jun 1, 2026