ProKnow DS
FDA 510(k) K251363 · Elekta Solutions AB
510(k) numberK251363
Submission
- Device name
- ProKnow DS
- Applicant
- Elekta Solutions AB
Stockholm, SE - Received
- May 1, 2025
- Decision date
- October 8, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ProKnow DS cleared by the FDA?
ProKnow DS (K251363) received a 510(k) decision of Substantially Equivalent on October 8, 2025, 160 days after the submission was received.
What is the product code of K251363?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.