FDA 510(k)

Bonelogic

K-Number: K203290 · 2021-02-05

Decision Date2021-02-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Bonelogic is the device name listed in this FDA 510(k) record. The listed applicant is Disior, Ltd.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K203290. 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 Bonelogic?

Bonelogic is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Disior, Ltd.. The 510(k) number is K203290.

When did Bonelogic receive FDA 510(k) clearance?

Bonelogic received FDA 510(k) clearance on 2021-02-05, under 510(k) number K203290.

Who is the listed applicant for Bonelogic?

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

What is the FDA product code for Bonelogic?

The FDA product code for Bonelogic is LLZ.

Other records listing Disior, Ltd. 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.

K253764ENOS Software Guided External Fixation System K250023SMART PCFD K240736SMART Bun-Yo-Matic X-Ray K240642SMART Bun-Yo-Matic CT K223757Bonelogic

Related Devices (Code: LLZ)

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid 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.