FDA 510(k)

NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE

K-Number: K081426 · 2008-06-04

ApplicantPhilips Medical Systems (Cleveland), Inc.

Decision Date2008-06-04

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE 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 2008-06-04 under 510(k) number K081426. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE?

NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE is a medical device that received FDA 510(k) clearance on 2008-06-04. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K081426.

When did NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE receive FDA 510(k) clearance?

NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE received FDA 510(k) clearance on 2008-06-04, under 510(k) number K081426.

Who is the listed applicant for NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE?

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 NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE?

The FDA product code for NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE is KPS.

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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.