Cleared Traditional

K864758 - DIASONICS SPA 5.O 27MM PROBE

K864758 is an FDA 510(k) clearance for DIASONICS SPA 5.O 27MM 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 95-day FDA review.

K864758 · Diasonics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
95d
Days
Class 2
Risk

K864758 is an FDA 510(k) clearance for the DIASONICS SPA 5.O 27MM 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 March 10, 1987 after a review of 95 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 - K864758

510(k) Number K864758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date March 10, 1987
Days to Decision 95 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
12d faster than avg
Panel avg: 107d · This submission: 95d
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 K864758.
7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE
K870748 · Philips Ultrasound, Inc. · Apr 1987
TRT TRANS-RECTAL TRANSDUCER
K870038 · Advanced Technology Laboratories, Inc. · Mar 1987
7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12
K863708 · Siemens Medical Solutions USA, Inc. · Mar 1987
DIASONICS SPA 3.5 MHZ, 30MM PROBE
K864812 · Diasonics, Inc. · Mar 1987
SERIES 620 RECTAL PROBE COVER
K864222 · General Electric Co. · Mar 1987
KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM
K862686 · Kontron Instruments, Inc. · Feb 1987