Cleared Traditional

K940671 - INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER

K940671 is an FDA 510(k) clearance for INTERSPEC APOGEE RX400 ULTRASOUND IMAGI..., 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 279-day FDA review.

K940671 · Interspec, Inc. · Radiology device
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Nov 1994
Decision
279d
Days
Class 2
Risk

K940671 is an FDA 510(k) clearance for the INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWM.... Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Interspec, Inc. (Ambler, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 279 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 - K940671

510(k) Number K940671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1994
Decision Date November 22, 1994
Days to Decision 279 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
172d slower than avg
Panel avg: 107d · This submission: 279d
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 259
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K940671.
ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
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DIAGNOSTIC ULTRASOUND IMAGING CATHETER
K940108 · Boston Scientific Corp · Dec 1994
SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION
K940804 · Peripheral Systems Group · Jun 1994
MODIFICATION OF ACUSON V510B TRANSDUCER
K933663 · Acuson Corp. · Jan 1994
SHEATHES, STERILE SHEATHES
K925869 · Mayer Laboratories · Jan 1994