Identity
- Trade Name
- WaterProof PROFILER FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- Radiation Therapy QA Device. For use with the 1230 3D SCANNER. FDA UDI
- Model / Reference
- 12300009Z FDA UDI
- Description
- Radiation Therapy QA Device. For use with the 1230 3D SCANNER. FDA UDI
Identifiers
- Catalog Number
- 12300009Z FDA UDI
- Primary DI / UDI-DI
- B01612300009Z0 FDA UDI
- 510(k) Number
- K142431 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
WaterProof PROFILER 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
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 530c53f6-6d2e-4cb5-b12e-9ef5f6e13f10 36 fields · synced Jun 8, 2026