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FDA 510(k)

ImplantMax Software

K-Number: K151152 · 2016-01-12

ApplicantSaturn Imaging, Inc.
Decision Date2016-01-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ImplantMax Software is the device name listed in this FDA 510(k) record. The listed applicant is Saturn Imaging, Inc.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K151152. 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 ImplantMax Software?

ImplantMax Software is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Saturn Imaging, Inc.. The 510(k) number is K151152.

When did ImplantMax Software receive FDA 510(k) clearance?

ImplantMax Software received FDA 510(k) clearance on 2016-01-12, under 510(k) number K151152.

Who is the listed applicant for ImplantMax Software?

The FDA 510(k) record lists Saturn Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImplantMax Software?

The FDA product code for ImplantMax Software is LLZ.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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