Identity
- Trade Name
- ArcCHECK FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- Radiation therapy QA device. FDA UDI
- Model / Reference
- 12200000Z FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 12200000Z FDA UDI
- Primary DI / UDI-DI
- B01612200000Z0 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
- Not 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
MR Unsafe FDA UDI
ArcCHECK by Sun Nuclear Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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- SRS MapCHECK — SUN NUCLEAR CORP.
- Adaptor Plate for GMF — Sun Nuclear Corporation
- Elekta IMF (Isocentric Mounting Fixture) — Sun Nuclear Corporation
- SRS MapCHECK — Sun Nuclear Corporation
- Siemens IMF (Isocentric Mounting Fixture) — Sun Nuclear Corporation
- Varian IMF (Isocentric Mounting Fixture) — Sun Nuclear Corporation
K142617 also covers:
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 28d4c7e5-6492-4019-b015-7e9d7127e817 37 fields · synced Jun 8, 2026