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Respiratory Gating for Scanners
EUDAMEDFDA 510(k)FDA UDIClass IIb (EU MDR)
Ref Respiratory Gating for Scanners (RGSC) 2.1510(k) K213927Ref Respiratory Gating for Scanners (RGSC) 2.0
Identity
- Trade Name
- Respiratory Gating for Scanners EUDAMEDRespiratory Gating for Scanners (RGSC) FDA UDI
- Generic Name
- Real-time position management respiratory gating system, optical FDA UDI
- Device Name
- Respiratory Gating for Scanners (RGSC) EUDAMED
- Model / Reference
- Respiratory Gating for Scanners (RGSC) 2.1 EUDAMEDRespiratory Gating for Scanners (RGSC) 2.0 EUDAMED2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856100006493 EUDAMED00856100006196 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200118PT EUDAMED
- 510(k) Number
- FDA Product Code
- JAK FDA 510(k)FDA UDI
- EMDN Code
- Z119099 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Real-time position management respiratory gating system, optical FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Respiratory Gating for Scanners by Varian Medical Systems, Inc — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213927 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K151533 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200118PT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (4)
- EUDAMED eb1b2ebd-79ce-4a23-9c9d-41fd210aaa0d 61 fields · synced Jul 30, 2026
- FDA 510(k) K213927 24 fields · synced May 18, 2026
- FDA UDI 0a0287a2-0bd3-4009-820a-01129a1a1918 33 fields · synced May 30, 2026
- EUDAMED c0375261-18f5-4e14-a64a-5cc184f24e1b 61 fields · synced Jul 30, 2026