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FDA 510(k)

aprevo® Digital Segmentation

K-Number: K231955 · 2023-11-03

ApplicantCarlsmed, Inc.
Decision Date2023-11-03
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

aprevo® Digital Segmentation is the device name listed in this FDA 510(k) record. The listed applicant is Carlsmed, Inc.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K231955. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the aprevo® Digital Segmentation?

aprevo® Digital Segmentation is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Carlsmed, Inc.. The 510(k) number is K231955.

When did aprevo® Digital Segmentation receive FDA 510(k) clearance?

aprevo® Digital Segmentation received FDA 510(k) clearance on 2023-11-03, under 510(k) number K231955.

Who is the listed applicant for aprevo® Digital Segmentation?

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

What is the FDA product code for aprevo® Digital Segmentation?

The FDA product code for aprevo® Digital Segmentation is QIH.

Other records listing Carlsmed, Inc. 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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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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