Cleared Traditional

K140651 - CELESTEION, PCA-9000A/2

K140651 is an FDA 510(k) clearance for CELESTEION, manufactured by Toshibamedical Systems Corporation. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K140651 · Toshibamedical Systems Corporation · Radiology device
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Jun 2014
Decision
90d
Days
Class 2
Risk

K140651 is an FDA 510(k) clearance for the CELESTEION, PCA-9000A/2. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Tustin, US). The FDA issued a Cleared decision on June 11, 2014 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toshibamedical Systems Corporation devices

FDA 510(k) Submission Details - K140651

510(k) Number K140651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2014
Decision Date June 11, 2014
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

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 Peers - KPS System, Tomography, Computed, Emission

All 367
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