Cleared Traditional

K900966 - EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGIN...

K900966 is the FDA 510(k) clearance for EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGIN... by Hitachi Medical Corp. of America. It is a Class 2 Obstetrics & Gynecology device (product code HGL) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K900966 · Hitachi Medical Corp. of America · Obstetrics & Gynecology device
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Sep 1990
Decision
195d
Days
Class 2
Risk

K900966 is an FDA 510(k) clearance for the EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Hitachi Medical Corp. of America (Tarrytown, US). The FDA issued a Cleared decision on September 12, 1990 after a review of 195 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 Hitachi Medical Corp. of America devices

Submission Details

510(k) Number K900966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1990
Decision Date September 12, 1990
Days to Decision 195 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
35d slower than avg
Panel avg: 160d · This submission: 195d
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 18
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K900966.
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
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ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K903316 · Ge Medical Systems Information Technologies · Aug 1990
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
K895449 · Ge Medical Systems Information Technologies · Mar 1990
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895647 · Advanced Technology Laboratories, Inc. · Dec 1989
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895123 · Advanced Technology Laboratories, Inc. · Nov 1989
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
K895026 · Hewlett-Packard Co. · Nov 1989