Cleared Traditional

K955942 - BLADDERSCAN BVI 5000

K955942 is an FDA 510(k) clearance for BLADDERSCAN BVI 5000, manufactured by Diagnostic Ultrasound Corp.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K955942 · Diagnostic Ultrasound Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
80d
Days
Class 2
Risk

K955942 is an FDA 510(k) clearance for the BLADDERSCAN BVI 5000. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Diagnostic Ultrasound Corp. (Redmond, US). The FDA issued a Cleared decision on March 15, 1996 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Ultrasound Corp. devices

FDA 510(k) Submission Details - K955942

510(k) Number K955942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date March 15, 1996
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
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 437
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K955942.
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SONOS IMAGING SYSTEM (2000/2500 & 1000/1500)
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ULTRA EASE
K950943 · Lectec Corp. · Mar 1996