Cleared Traditional

K840623 - OBSTETRICAL ULTRASOUND COMPUTER

K840623 is the FDA 510(k) clearance for OBSTETRICAL ULTRASOUND COMPUTER by R & S Systems. It is a Class 2 Obstetrics & Gynecology device (product code HEM) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K840623 · R & S Systems · Obstetrics & Gynecology device
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May 1984
Decision
87d
Days
Class 2
Risk

K840623 is an FDA 510(k) clearance for the OBSTETRICAL ULTRASOUND COMPUTER. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by R & S Systems (Mchenry, US). The FDA issued a Cleared decision on May 11, 1984 after a review of 87 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 R & S Systems devices

Submission Details

510(k) Number K840623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1984
Decision Date May 11, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 160d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (HEM) and FDA review panel - the closest regulatory comparables to K840623.
MODEL U-1000 ULTRASONIC SCANNER
K851902 · Fukuda Denshi USA, Inc. · Sep 1985
INTRA VAGINAL TRANSDUCER
K853407 · Advanced Technology Laboratories, Inc. · Sep 1985
OB ULTRASOUND LINEAR SCANNER 630
K842261 · Ge Medical Systems Information Technologies · Sep 1984
DATASON DB ULTRASOUND IMAGING SYSTEM
K810305 · General Electric Co. · Mar 1981
ULTRASONIC IMAGER
K780876 · Air-Shields, Inc. · Jun 1978
V.I. OCTOSON ULTRASONIC SYSTEM
K760874 · General Electric Co. · Dec 1976