Cleared Traditional

K944017 - OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM

K944017 is an FDA 510(k) clearance for OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM, manufactured by Olympus America, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K944017 · Olympus America, Inc. · Radiology device
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Jun 1995
Decision
301d
Days
Class 2
Risk

K944017 is an FDA 510(k) clearance for the OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Olympus America, Inc. devices

FDA 510(k) Submission Details - K944017

510(k) Number K944017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date June 13, 1995
Days to Decision 301 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
194d slower than avg
Panel avg: 107d · This submission: 301d
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 337
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K944017.
GE B510 TRANSDUCER
K951723 · GE Medical Systems · Nov 1995
ULTRASOUND PROBE BIOPSY ACCESSORIES
K953430 · Biosound, Inc. · Oct 1995
LP-12 LAPAROSCOPIC PROBE
K941935 · Biosound, Inc. · Sep 1995
7050 ULTRASOUND IMAGING SYSTEM
K944287 · Biosound, Inc. · Jun 1995
SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM
K945796 · Sharplan Lasers, Inc. · May 1995
PW DOPPLER VASCULAR PROBES
K935994 · Koven Technology, Inc. · May 1995