Cleared Traditional

K933056 - DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535

K933056 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, manufactured by B&K Medical. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K933056 · B&K Medical · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
372d
Days
Class 2
Risk

K933056 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by B&K Medical (Gentofte, DK). The FDA issued a Cleared decision on June 24, 1994 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 B&K Medical devices

FDA 510(k) Submission Details - K933056

510(k) Number K933056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1993
Decision Date June 24, 1994
Days to Decision 372 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 107d · This submission: 372d
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 438
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K933056.
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
HP 77010CF
K943634 · Hewlett-Packard Co. · Sep 1994
CAPASEE
K933747 · Toshiba America Medical Systems, In.C · May 1994
ORION DIAGNOSTIC ULTRASOUND SYSTEM
K930768 · GE Medical Systems · Mar 1994
CVI-Q(TM) OPTION FOR P700
K924184 · Philips Medical Systems, Inc. · Dec 1993