Identifiers
- 510(k) Number
- K251363 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Radiology devices such as the ProKnow DS from Elekta Solutions AB are subject to substantial equivalence regulations. These regulations dictate that medical imaging devices must demonstrate their safety and effectiveness in a real-world clinical setting before being approved for sale. The device's performance, image quality, and user interface must be comparable to its international counterparts.
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 | K251363 | Class II | Active |
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Manufacturer
- Manufacturer
- Elekta Solutions Ab
Sources (1)
- FDA 510(k) K251363 24 fields · synced Jul 12, 2026