Cleared Traditional

K852362 - UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQ...

K852362 is the FDA 510(k) clearance for UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQ... by Johnson & Johnson Professionals, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K852362 · Johnson & Johnson Professionals, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
149d
Days
Class 2
Risk

K852362 is an FDA 510(k) clearance for the UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Ramsey, US). The FDA issued a Cleared decision on October 31, 1985 after a review of 149 days - within the typical 510(k) review window.

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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K852362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1985
Decision Date October 31, 1985
Days to Decision 149 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 107d · This submission: 149d
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 423
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K852362.
SDL-32 ELECTRONIC LINEAR SCANNER
K850834 · Shimadzu Corp. · Oct 1985
UNIVERSAL SERVICE MODULE
K851446 · Diasonics, Inc. · Oct 1985
DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM
K851860 · Diasonics, Inc. · Oct 1985
STORZ SOLID-STANDOFF PACHYMETRY PROBE
K853087 · Storz Instrument Co. · Oct 1985
POLYGEL ULTRASOUND GEL
K851895 · Parker Laboratories, Inc. · Sep 1985
RT2600(115V)(220/240V) #H4008A & H4008AE
K851807 · General Electric Co. · Sep 1985