Cleared Traditional

K861931 - 645OB SECTOR/LINEAR ULTRASOUND SCANNER

K861931 is an FDA 510(k) clearance for 645OB SECTOR/LINEAR ULTRASOUND SCANNER, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code HEM cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K861931 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
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Jul 1986
Decision
72d
Days
Class 2
Risk

K861931 is an FDA 510(k) clearance for the 645OB SECTOR/LINEAR ULTRASOUND SCANNER. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on July 31, 1986 after a review of 72 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K861931

510(k) Number K861931 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 20, 1986
Decision Date July 31, 1986
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 160d · This submission: 72d
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 16
Devices cleared under the same product code (HEM) and FDA review panel - the closest regulatory comparables to K861931.
SIEMENS INTRAVAGINAL TRANSDUCER
K885061 · Siemens Medical Solutions USA, Inc. · Feb 1989
ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
K881185 · Philips Medical Systems (Cleveland), Inc. · Jun 1988
SONORANGER TRANSVAGINAL PROBE
K862627 · Ausonics Pty , Ltd. · Aug 1986
5 MHZ INTRACAVITARY PROBE, MODEL H4222V
K860233 · General Electric Co. · Jun 1986
5.0 MHZ INTRACAVITARY SECTOR PROBE
K853711 · General Electric Co. · Dec 1985
MODEL U-1000 ULTRASONIC SCANNER
K851902 · Fukuda Denshi USA, Inc. · Sep 1985