Cleared Traditional

K933747 - CAPASEE

K933747 is an FDA 510(k) clearance for CAPASEE, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K933747 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
283d
Days
Class 2
Risk

K933747 is an FDA 510(k) clearance for the CAPASEE. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on May 13, 1994 after a review of 283 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K933747

510(k) Number K933747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1993
Decision Date May 13, 1994
Days to Decision 283 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
176d slower than avg
Panel avg: 107d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 650
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K933747.
ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)
K930964 · Acuson Corp. · Oct 1994
HP 77010CF
K943634 · Hewlett-Packard Co. · Sep 1994
CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT
K933320 · Cardio Metrics, Inc. · Aug 1994
ORION DIAGNOSTIC ULTRASOUND SYSTEM
K930768 · GE Medical Systems · Mar 1994
FULL VIEW DIGITAL STORAGE SYSTEM
K934908 · International Imaging Electronics · Jan 1994
CVI-Q(TM) OPTION FOR P700
K924184 · Philips Medical Systems, Inc. · Dec 1993