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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2025-10-08 under 510(k) 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. The listed applicant is Elekta Solutions AB. The 510(k) number is K251363.

When did ProKnow DS receive FDA 510(k) clearance?

ProKnow DS received FDA 510(k) clearance on 2025-10-08, under 510(k) number K251363.

Who is the listed applicant for ProKnow DS?

The FDA 510(k) record lists Elekta Solutions AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProKnow DS?

The FDA product code for ProKnow DS is LLZ.

Other records listing Elekta Solutions AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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.

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