Cleared Traditional

PS SYSTEM WITH SD-200 DOPPLER (K861358) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K861358 · Johnson & Johnson Professionals, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
111d
Days
Class 2
Risk

K861358 is an FDA 510(k) clearance for the PS SYSTEM WITH SD-200 DOPPLER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Ramsey, US). The FDA issued a Cleared decision on July 30, 1986 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 K861358 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 10, 1986
Decision Date July 30, 1986
Days to Decision 111 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
4d slower than avg
Panel avg: 107d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 92
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K861358.
7.5 MHZ LINEAR PROBE, CAT. NO. H4221H
K862844 · General Electric Co. · Nov 1986
BI-PLANE TRANSRECTAL PROBE NUMBER H4221T
K862911 · General Electric Co. · Oct 1986
5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM
K860009 · Johnson & Johnson Professionals, Inc. · Aug 1986
7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER)
K861228 · General Electric Co. · Jul 1986
RT3600(115V) RT3600(220/240V)
K853249 · General Electric Co. · Dec 1985
MODEL 21225A CW COPPLER/IMAGING TRANSDUCER
K852132 · Hewlett-Packard Co. · Aug 1985