Identity
- Trade Name
- Halcyon Couch Positioning Plate FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- The Halcyon Couch Positioning Plate is an accessory to the 3D SCANNER system that allows the 3D SCANNER Water Tank to be placed and positioned on a Varian Halcyon delivery system couch. The Couch Positioning Plate is indexed to the Halcyon couch and coordinate system; SNC Dosimetry software Autosetup™ has been modified for Halcyon couch measurements using a new, patent-pending leveling technique. FDA UDI
- Model / Reference
- 1231410Z FDA UDI
- Description
- The Halcyon Couch Positioning Plate is an accessory to the 3D SCANNER system that allows the 3D SCANNER Water Tank to be placed and positioned on a Varian Halcyon delivery system couch. The Couch Positioning Plate is indexed to the Halcyon couch and coordinate system; SNC Dosimetry software Autosetup™ has been modified for Halcyon couch measurements using a new, patent-pending leveling technique. FDA UDI
Identifiers
- Catalog Number
- 1231410Z FDA UDI
- Primary DI / UDI-DI
- 05060608880201 FDA UDI
- 510(k) Number
- K101992 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Accelerator system quality assurance device 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Accelerator system quality assurance device
Halcyon Couch Positioning Plate by Sun Nuclear Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Accelerator system quality assurance device.
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- Detector Holder — IBA Dosimetry GmbH · Class II
- myQA®Daily (Software) — IBA Dosimetry GmbH · Class I
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Cleared under the same submission
K101992 also covers:
- 3D MiniLift — SUN NUCLEAR CORP.
- 3D SCANNER (BNC) — SUN NUCLEAR CORP.
- 3D Reservoir — Sun Nuclear Corporation
- 3D Reservoir — Sun Nuclear Corporation
- 3D SCANNER (TNC) — Sun Nuclear Corporation
- 3D SCANNER (TNC) — Sun Nuclear Corporation
- 3D TPR — Sun Nuclear Corporation
- Halcyon Bracket — Sun Nuclear Corporation
- SunSCAN 3D — Sun Nuclear Corporation
- SunSCAN 3D — Sun Nuclear Corporation
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
- Sun Nuclear Corporation
Sources (1)
- FDA UDI 8acda1c7-54bf-41e0-89e8-98f66461d5e3 36 fields · synced Jun 8, 2026