Cleared Traditional

K082244 - PCA-8000A

K082244 is the FDA 510(k) clearance for PCA-8000A by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K082244 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
13d
Days
Class 2
Risk

K082244 is an FDA 510(k) clearance for the PCA-8000A, MARK 11, PET / CT SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on August 21, 2008 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K082244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2008
Decision Date August 21, 2008
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 247
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K082244.
AUTOSPECT
K090403 · Philips Medical Systems (Cleveland), Inc. · Mar 2009
BIOGRAPH 16 TRUE POINT SYSTEMS
K083852 · Siemens Medical Solutions USA, Inc. · Mar 2009
SYMBIA, VERSION 4.0
K082506 · Siemens Medical Solutions USA, Inc. · Nov 2008
BIOGRAPH HD FAMILY
K081453 · Siemens Medical Solutions USA, Inc. · Jun 2008
OPTIMA PET/CT 560
K081496 · Ge Medical Systems, LLC · Jun 2008
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
K081426 · Philips Medical Systems (Cleveland), Inc. · Jun 2008