Identity
- Trade Name
- SRS MapCHECK FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- Radiation therapy QA device. FDA UDI
- Model / Reference
- 11790000Z FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 11790000Z FDA UDI
- Primary DI / UDI-DI
- B01611790000Z0 FDA UDI
- 510(k) Number
- K131466 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
MR Unsafe FDA UDI
Category: Accelerator system quality assurance device
SRS MapCHECK by Sun Nuclear Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- StereoPHAN — Sun Nuclear Corporation · Class I
- Detector Holder — IBA Dosimetry GmbH · Class II
- myQA®Daily (Software) — IBA Dosimetry GmbH · Class I
Cleared under the same submission
K131466 also covers:
- MapCHECK 3 — SUN NUCLEAR CORP.
- MapCHECK2 — 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 Corp.
Sources (2)
- FDA UDI 3b0fa1d4-625c-4edf-bc04-5c08b1bfaee8 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 20, 2026