Identifiers
- 510(k) Number
- K011845 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
MILLCOMP is a high-precision radiation registration device designed for accurate and reliable medical imaging, particularly in radiology. This device features advanced technology, including linear accelerators, to provide precise measurement of patient anatomy. Its accuracy and reliability have been consistently demonstrated through various clinical trials and studies.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011845 | Class II | Active |
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Manufacturer
- Manufacturer
- Math Resolutions, Llc
Sources (1)
- FDA 510(k) K011845 24 fields · synced Jul 19, 2026