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FDA 510(k)

LUNG NODULE ASSESSMENT AND COMPARISON OPTION

K-Number: K023785 · 2003-02-10

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2003-02-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUNG NODULE ASSESSMENT AND COMPARISON OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2003-02-10 under 510(k) number K023785. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUNG NODULE ASSESSMENT AND COMPARISON OPTION?

LUNG NODULE ASSESSMENT AND COMPARISON OPTION is a medical device that received FDA 510(k) clearance on 2003-02-10. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K023785.

When did LUNG NODULE ASSESSMENT AND COMPARISON OPTION receive FDA 510(k) clearance?

LUNG NODULE ASSESSMENT AND COMPARISON OPTION received FDA 510(k) clearance on 2003-02-10, under 510(k) number K023785.

Who is the listed applicant for LUNG NODULE ASSESSMENT AND COMPARISON OPTION?

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

What is the FDA product code for LUNG NODULE ASSESSMENT AND COMPARISON OPTION?

The FDA product code for LUNG NODULE ASSESSMENT AND COMPARISON OPTION is JAK.

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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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