ProKnow DS
K-Number: K251363 · 2025-10-08
ApplicantElekta Solutions AB
Decision Date2025-10-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ProKnow DS is a medical device manufactured by Elekta Solutions AB. It received FDA 510(k) clearance on 2025-10-08 under approval number K251363. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ProKnow DS?
ProKnow DS is a medical device that received FDA 510(k) clearance on 2025-10-08. It is manufactured by Elekta Solutions AB. The 510(k) number is K251363.
When was ProKnow DS approved by the FDA?
ProKnow DS received FDA 510(k) clearance on 2025-10-08, under approval number K251363.
What company makes ProKnow DS?
ProKnow DS is manufactured by Elekta Solutions AB.
What is the FDA product code for ProKnow DS?
The FDA product code for ProKnow DS is LLZ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.