Cleared Traditional

K860361 - DIASONICS 3.5 GWA 30MM PROBE

K860361 is an FDA 510(k) clearance for DIASONICS 3.5 GWA 30MM PROBE, manufactured by Diasonics, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K860361 · Diasonics, Inc. · Radiology device
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May 1986
Decision
117d
Days
Class 2
Risk

K860361 is an FDA 510(k) clearance for the DIASONICS 3.5 GWA 30MM PROBE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Diasonics, Inc. (Milipitas, US). The FDA issued a Cleared decision on May 27, 1986 after a review of 117 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 Diasonics, Inc. devices

FDA 510(k) Submission Details - K860361

510(k) Number K860361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1986
Decision Date May 27, 1986
Days to Decision 117 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
10d slower than avg
Panel avg: 107d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

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 204
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K860361.
SDL-300
K854337 · Shimadzu Corp. · Jun 1986
STORZ, ALPHA II BIOMETRIC RULER
K860553 · Storz Instrument Co. · Jun 1986
CONVEX PROBE, PVE-382M
K860281 · Toshiba Medical Systems · May 1986
6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU
K844772 · Philips Medical Systems, Inc. · Apr 1986
ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M
K852947 · Advanced Technology Laboratories, Inc. · Jan 1986
RT3600(115V) RT3600(220/240V)
K853249 · General Electric Co. · Dec 1985