Cleared Traditional

280SL IMAGING SYSTEM TRANVAGINAL PROBES (K864151) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864151 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
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Mar 1987
Decision
155d
Days
Class 2
Risk

K864151 is an FDA 510(k) clearance for the 280SL IMAGING SYSTEM TRANVAGINAL PROBES. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on March 27, 1987 after a review of 155 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2960 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K864151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1986
Decision Date March 27, 1987
Days to Decision 155 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
5d faster than avg
Panel avg: 160d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGL Transducer, Ultrasonic, Obstetric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2960
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 - HGL Transducer, Ultrasonic, Obstetric

All 7
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K864151.
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
K895449 · Ge Medical Systems Information Technologies · Mar 1990
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
K895026 · Hewlett-Packard Co. · Nov 1989
SIEMENS INTRAVAGINAL TRANSDUCER
K881405 · Siemens Medical Solutions USA, Inc. · Aug 1988
TRANSVAGINAL TRANSDUCER, 5MHZ
K860234 · Philips Medical Systems, Inc. · May 1986
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
K860313 · Johnson & Johnson Professionals, Inc. · Mar 1986
ARTIUS SYSTEM
K771151 · General Electric Co. · Aug 1977