Cleared Traditional

K860568 - ULTRASONIC IMAGING SYSTEM (MODIFIED)

K860568 is an FDA 510(k) clearance for ULTRASONIC IMAGING SYSTEM (MODIFIED), manufactured by Interspec, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K860568 · Interspec, Inc. · Radiology device
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Aug 1986
Decision
178d
Days
Class 2
Risk

K860568 is an FDA 510(k) clearance for the ULTRASONIC IMAGING SYSTEM (MODIFIED). Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Interspec, Inc. (Conshohocken, US). The FDA issued a Cleared decision on August 11, 1986 after a review of 178 days - an extended review cycle.

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 Interspec, Inc. devices

FDA 510(k) Submission Details - K860568

510(k) Number K860568 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 14, 1986
Decision Date August 11, 1986
Days to Decision 178 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
71d slower than avg
Panel avg: 107d · This submission: 178d
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 260
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K860568.
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
PS SYSTEM WITH SD-200 DOPPLER
K861358 · Johnson & Johnson Professionals, Inc. · Jul 1986
SONOLAYER-L, SAL-38A, WITH SCANNER SAL-38AS
K860531 · Toshiba Medical Systems · Jul 1986
VASOVIEW DUPLEX IMAGING SYSTEM
K861237 · Sonicaid, Inc. · Jul 1986