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FDA 510(k)

ATLAS-BASED AUTOSEGMENTATION

K-Number: K080799 · 2008-08-07

ApplicantComputerized Medical Systems, Inc.
Decision Date2008-08-07
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATLAS-BASED AUTOSEGMENTATION is the device name listed in this FDA 510(k) record. The listed applicant is Computerized Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-08-07 under 510(k) number K080799. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLAS-BASED AUTOSEGMENTATION?

ATLAS-BASED AUTOSEGMENTATION is a medical device that received FDA 510(k) clearance on 2008-08-07. The listed applicant is Computerized Medical Systems, Inc.. The 510(k) number is K080799.

When did ATLAS-BASED AUTOSEGMENTATION receive FDA 510(k) clearance?

ATLAS-BASED AUTOSEGMENTATION received FDA 510(k) clearance on 2008-08-07, under 510(k) number K080799.

Who is the listed applicant for ATLAS-BASED AUTOSEGMENTATION?

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

What is the FDA product code for ATLAS-BASED AUTOSEGMENTATION?

The FDA product code for ATLAS-BASED AUTOSEGMENTATION is LHN.

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Related Devices (Code: LHN)

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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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