Cleared Traditional

LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM (K913472) - FDA 510(k) Clearance

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

K913472 · Baxter Healthcare Corp · Radiology device
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Mar 1992
Decision
221d
Days
Class 2
Risk

K913472 is an FDA 510(k) clearance for the LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on March 13, 1992 after a review of 221 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K913472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1991
Decision Date March 13, 1992
Days to Decision 221 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 107d · This submission: 221d
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 63
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K913472.
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K921036 · Hewlett-Packard Co. · May 1992
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K902245 · Boston Scientific Corp · Oct 1990
RADIUS AND SONOCHROME
K902070 · General Electric Co. · Aug 1990
SIEMENS ENDO-P-PROBE
K897098 · Siemens Medical Solutions USA, Inc. · Feb 1990