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FDA 510(k)

FractureDetect (FX)

K-Number: K193417 · 2020-07-30

ApplicantImagen Technologies, Inc.
Decision Date2020-07-30
Product CodeQBS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FractureDetect (FX) is a medical device manufactured by Imagen Technologies, Inc.. It received FDA 510(k) clearance on 2020-07-30 under approval number K193417. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FractureDetect (FX)?

FractureDetect (FX) is a medical device that received FDA 510(k) clearance on 2020-07-30. It is manufactured by Imagen Technologies, Inc.. The 510(k) number is K193417.

When was FractureDetect (FX) approved by the FDA?

FractureDetect (FX) received FDA 510(k) clearance on 2020-07-30, under approval number K193417.

What company makes FractureDetect (FX)?

FractureDetect (FX) is manufactured by Imagen Technologies, Inc..

What is the FDA product code for FractureDetect (FX)?

The FDA product code for FractureDetect (FX) is QBS.

Other Devices by Imagen Technologies, Inc.

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Related Devices (Code: QBS)

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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.

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