Identity
- Trade Name
- RPM Respiratory Gating System FDA UDI
- Generic Name
- Real-time position management respiratory gating system, optical FDA UDI
- Model / Reference
- 1.8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899475002479 FDA UDI
- 510(k) Number
- K102024 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Real-time position management respiratory gating system, optical 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
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
RPM Respiratory Gating System by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Real-time position management respiratory gating system, optical.
- Respiratory Gating for Scanners (RGSC) — Varian Medical Systems Imaging Laboratory GmbH · Class II
- Identify — Varian Medical Systems, Inc · Class II
- Varian RPM Gating Marker Block (6 Dot) — Varian Medical Systems, Inc · Class II
- Beacon Care Package - Surface — Varian Medical Systems, Inc · Class II
- RPM Respiratory Gating System — Varian Medical Systems, Inc · Class II
- Varian IDENTIFY — Varian Medical Systems, Inc · Class II
- Varian RPM Gating Marker Block (2 Dot) — Varian Medical Systems, Inc · Class II
- Varian RPM Respiratory Gating System — Varian Medical Systems, Inc · Class II
Cleared under the same submission
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, Inc
Sources (1)
- FDA UDI 74713607-3425-4f3c-8544-c3ce5a9e1492 33 fields · synced Jun 8, 2026