Cleared Traditional

K130960 - SURESUBTRACTION ORTHO

K130960 is the FDA 510(k) clearance for SURESUBTRACTION ORTHO by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K130960 · Toshibamedical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
137d
Days
Class 2
Risk

K130960 is an FDA 510(k) clearance for the SURESUBTRACTION ORTHO. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Tustin, US). The FDA issued a Cleared decision on August 20, 2013 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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

Submission Details

510(k) Number K130960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2013
Decision Date August 20, 2013
Days to Decision 137 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
30d slower than avg
Panel avg: 107d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 586
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K130960.
MYOPERFUSION
K132523 · Toshibamedical Systems Corporation · Dec 2013
AQUILION ONE VISION, V6.0
K132222 · Toshibamedical Systems Corporation · Nov 2013
OPTIMA CT660
K131576 · Ge Medical Systems, LLC · Aug 2013
AQUILION PRIME, V5.00
K130645 · Toshibamedical Systems Corporation · Jun 2013
AQUILION LB TRITON V4.91
K123500 · Toshibamedical Systems Corporation · May 2013
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
K123509 · Hitachi Medical Systems America, Inc. · Mar 2013