Identity
- Trade Name
- MapCHECK 3 EUDAMEDFDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- MapCHECK 3 EUDAMEDRadiation therapy QA device. FDA UDI
- Model / Reference
- 1178 EUDAMED1178400Z FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 11780000Z FDA UDI
- Primary DI / UDI-DI
- 05060608880003 EUDAMEDFDA UDI
- Basic UDI-DI
- 506060888DAMPCHECK3S9 EUDAMED
- 510(k) Number
- K131466 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MapCHECK 3 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:
- MapCHECK2 — SUN NUCLEAR CORP.
- 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
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 3e3b13b3-4335-4bf6-98d5-f08afd783849 36 fields · synced Jul 18, 2026
- EUDAMED dd8c0c34-971e-4e3d-b71a-e6ac19fd76af 61 fields · synced Jul 18, 2026