Cleared Traditional

K951976 - ECHO. AKHO

K951976 is an FDA 510(k) clearance for ECHO. AKHO, manufactured by Alliance Medical, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 456-day FDA review.

K951976 · Alliance Medical, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
456d
Days
Class 2
Risk

K951976 is an FDA 510(k) clearance for the ECHO. AKHO. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Alliance Medical, Inc. (St-Laurent, Quebec, CA). The FDA issued a Cleared decision on July 26, 1996 after a review of 456 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Alliance Medical, Inc. devices

FDA 510(k) Submission Details - K951976

510(k) Number K951976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1995
Decision Date July 26, 1996
Days to Decision 456 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
349d slower than avg
Panel avg: 107d · This submission: 456d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 567
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K951976.
LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM
K960700 · GE Medical Systems · Aug 1996
MENTOR ADVENT A/B SYSTEM
K960765 · Mentor Ophthalmics, Inc. · Aug 1996
FIRST BEAT/CARDIO BEAT/CALC
K961116 · Medasonics, Inc. · Aug 1996
KILTEX PROBE COVER
K961029 · Kiltex Corp. · Jul 1996
EUB-905
K962308 · Hitachi Medical Corp. of America · Jul 1996
PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065
K954884 · Vingmed Sound, Inc. · May 1996