Cleared Traditional

K946300 - DOPPLEX SURGICAL PROBES

K946300 is an FDA 510(k) clearance for DOPPLEX SURGICAL PROBES, manufactured by Hne Healthcare, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K946300 · Hne Healthcare, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
210d
Days
Class 2
Risk

K946300 is an FDA 510(k) clearance for the DOPPLEX SURGICAL PROBES. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Hne Healthcare, Inc. (Manalapan, US). The FDA issued a Cleared decision on July 26, 1995 after a review of 210 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 Hne Healthcare, Inc. devices

FDA 510(k) Submission Details - K946300

510(k) Number K946300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1994
Decision Date July 26, 1995
Days to Decision 210 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 107d · This submission: 210d
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 229
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K946300.
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
OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM
K944017 · Olympus America, Inc. · Jun 1995
7050 ULTRASOUND IMAGING SYSTEM
K944287 · Biosound, Inc. · Jun 1995
SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM
K945796 · Sharplan Lasers, Inc. · May 1995