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FDA 510(k)

Chondral Quant

K-Number: K231351 · 2023-07-13

ApplicantSiemens Medical Soultions USA, Inc.
Decision Date2023-07-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Chondral Quant is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Soultions USA, Inc.. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K231351. 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 Chondral Quant?

Chondral Quant is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Siemens Medical Soultions USA, Inc.. The 510(k) number is K231351.

When did Chondral Quant receive FDA 510(k) clearance?

Chondral Quant received FDA 510(k) clearance on 2023-07-13, under 510(k) number K231351.

Who is the listed applicant for Chondral Quant?

The FDA 510(k) record lists Siemens Medical Soultions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chondral Quant?

The FDA product code for Chondral Quant is LLZ.

Other records listing Siemens Medical Soultions USA, Inc. as applicant

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Related Devices (Code: LLZ)

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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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