Cleared Traditional

K133324 - SURESUBTRACTION LUNG

K133324 is the FDA 510(k) clearance for SURESUBTRACTION LUNG by Toshiba Medical Systems Corporation, Japan. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K133324 · Toshiba Medical Systems Corporation, Japan · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
311d
Days
Class 2
Risk

K133324 is an FDA 510(k) clearance for the SURESUBTRACTION LUNG. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshiba Medical Systems Corporation, Japan (Tustin, US). The FDA issued a Cleared decision on September 5, 2014 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Toshiba Medical Systems Corporation, Japan devices

Submission Details

510(k) Number K133324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2013
Decision Date September 05, 2014
Days to Decision 311 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 107d · This submission: 311d
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 590
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K133324.
SYNGO CT SINGLE SOURCE DUAL ENERGY
K133677 · Siemens Medical Solutions USA, Inc. · Oct 2014
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
K133603 · Philips Medical Systems · Sep 2014
SOMATOM SCOPE/SOMATOM SCOPE POWER
K140912 · Siemens Medical Solutions USA, Inc. · Sep 2014
AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT
K134025 · Toshibamedical Systems Corporation · Sep 2014
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
K140232 · Siemens Medical Solutions USA, Inc. · Aug 2014
SYNGO, CT DUAL ENERGY
K133648 · Siemens Medical Solutions USA, Inc. · Jul 2014