FDA 510(k)

PCA-8000A, MARK 11, PET / CT SYSTEM

K-Number: K082244 · 2008-08-21

ApplicantToshiba America Medical Systems, In.C

Decision Date2008-08-21

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PCA-8000A, MARK 11, PET / CT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2008-08-21 under 510(k) number K082244. 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 PCA-8000A, MARK 11, PET / CT SYSTEM?

PCA-8000A, MARK 11, PET / CT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-21. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K082244.

When did PCA-8000A, MARK 11, PET / CT SYSTEM receive FDA 510(k) clearance?

PCA-8000A, MARK 11, PET / CT SYSTEM received FDA 510(k) clearance on 2008-08-21, under 510(k) number K082244.

Who is the listed applicant for PCA-8000A, MARK 11, PET / CT SYSTEM?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PCA-8000A, MARK 11, PET / CT SYSTEM?

The FDA product code for PCA-8000A, MARK 11, PET / CT SYSTEM is KPS.

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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.