Cleared Traditional

K951393 - ABACUS OB ULTRASOUNG COMPUTER SOFTWARE

K951393 is an FDA 510(k) clearance for ABACUS OB ULTRASOUNG COMPUTER SOFTWARE, manufactured by Solomon Technology Labs. The device is a Class 2 Obstetrics & Gynecology device with product code HEM cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K951393 · Solomon Technology Labs · Obstetrics & Gynecology device
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May 1995
Decision
35d
Days
Class 2
Risk

K951393 is an FDA 510(k) clearance for the ABACUS OB ULTRASOUNG COMPUTER SOFTWARE. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by Solomon Technology Labs (Chandler, US). The FDA issued a Cleared decision on May 1, 1995 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2225 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Solomon Technology Labs devices

FDA 510(k) Submission Details - K951393

510(k) Number K951393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date May 01, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 160d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEM Device Classification - Class 2, Special Controls

Product Code HEM Imager, Ultrasonic Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2225
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HEM Imager, Ultrasonic Obstetric-gynecologic

All 18
Devices cleared under the same product code (HEM) and FDA review panel - the closest regulatory comparables to K951393.
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