Identity
- Trade Name
- Halcyon Bracket FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an electrical connection to the 3D SCANNER motors when the 3D SCANNER Water Tank is used with the Varian Halcyon delivery system. FDA UDI
- Model / Reference
- 1231405Z FDA UDI
- Description
- The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an electrical connection to the 3D SCANNER motors when the 3D SCANNER Water Tank is used with the Varian Halcyon delivery system. FDA UDI
Identifiers
- Catalog Number
- 1231405Z FDA UDI
- Primary DI / UDI-DI
- 05060608880195 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 Bracket by Sun Nuclear Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Couch Positioning Plate — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (1)
- FDA UDI 74845683-d3c2-4949-b32a-a6270df406ea 36 fields · synced Jun 8, 2026