Cleared Traditional

K943303 - PVK-357AT

K943303 is the FDA 510(k) clearance for PVK-357AT by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K943303 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
210d
Days
Class 2
Risk

K943303 is an FDA 510(k) clearance for the PVK-357AT. 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 February 3, 1995 after a review of 210 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

Submission Details

510(k) Number K943303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1994
Decision Date February 03, 1995
Days to Decision 210 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
103d slower than avg
Panel avg: 107d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 408
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K943303.
EUB-555A+
K945795 · Hitachi Medical Corp. of America · Oct 1995
SIEMENS SONOLINE 4XX
K946179 · Siemens Medical Solutions USA, Inc. · Oct 1995
4000 AU ULTRASOUND IMAGING SYSTEM
K944485 · Biosound, Inc. · May 1995
SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM
K943113 · Aloka Co., Ltd. · Feb 1995
SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.
K931021 · Shimadzu Medical Systems · Nov 1994
ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)
K930964 · Acuson Corp. · Oct 1994