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Pca-8000A, Mark 11, Pet / CT System

by Toshiba America Medical Systems, In.C

510(k) K082244

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082244 Date21 Aug 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PCA-8000A, MARK 11, PET / CT SYSTEM is a medical device designed to acquire positron emission tomography (PET) images of any region of the whole body simultaneously with computed tomography (CT) images of the same region. This system is intended to be used for attenuation correction and anatomical localization in diagnostic imaging.

The device is supplied as a single-use system and is regulated under FDA 510(k) clearance. It is intended for use in radiology and requires proper storage and handling according to manufacturer guidelines. The system is classified as a Class II medical device under regulation 892.1200.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the PCA-8000A PET/CT system?

    The system is designed to acquire positron emission tomography (PET) images of the entire body simultaneously with computed tomography (CT) images of the same region. This dual-modality imaging is intended for attenuation correction and anatomical localization in diagnostic radiology.

  • How is the device regulated and what is its classification?

    The PCA-8000A is a Class II medical device regulated under FDA 510(k) clearance. It is classified under regulation 892.1200 and is intended for use in radiology.

  • What are the storage and handling requirements for this system?

    The device requires proper storage and handling according to the manufacturer's guidelines. As a medical imaging system, it must be maintained in a controlled environment to ensure optimal performance and safety.

  • Is the PCA-8000A intended for single-use or reuse?

    The device is supplied as a single-use system. This classification implies it is designed for one-time use and should not be reused to maintain safety and regulatory compliance.