Identity
- Trade Name
- 3D TPR FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio. FDA UDI
- Model / Reference
- 1230000-4Z FDA UDI
- Description
- Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio. FDA UDI
Identifiers
- Catalog Number
- 1230000-4Z FDA UDI
- Primary DI / UDI-DI
- 05060608880928 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
3d Tpr by Sun Nuclear Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Accelerator system quality assurance device.
- Qumulate — Varian Medical Systems, Inc · Class I
- Blue Phantom² — IBA Dosimetry GmbH · Class II
- Standard Imaging QA StereoChecker — STANDARD IMAGING, INC. · Class I
- Detector Holder — IBA Dosimetry GmbH · Class II
- Standard Imaging TomoScanner — STANDARD IMAGING, INC. · Class I
- Detector Holder — IBA Dosimetry GmbH · Class II
- myQA®Daily (Software) — IBA Dosimetry GmbH · Class I
- Vista — Modus Medical Devices Inc · Class I
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
- Halcyon Bracket — 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 d2eadf9b-563a-4274-9e37-21b104d2da71 36 fields · synced Jun 8, 2026