Cleared Traditional

K895449 - ALOKA MODEL SSD-650 ULTRASOUND IMAGING ...

K895449 is an FDA 510(k) clearance for ALOKA MODEL SSD-650 ULTRASOUND IMAGING ..., manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code HGL cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K895449 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
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Mar 1990
Decision
194d
Days
Class 2
Risk

K895449 is an FDA 510(k) clearance for the ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM. 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 5, 1990 after a review of 194 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

FDA 510(k) Submission Details - K895449

510(k) Number K895449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1989
Decision Date March 05, 1990
Days to Decision 194 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
34d slower than avg
Panel avg: 160d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGL Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K895449.
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K903348 · Advanced Technology Laboratories, Inc. · Oct 1990
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
K900966 · Hitachi Medical Corp. of America · Sep 1990
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K903316 · Ge Medical Systems Information Technologies · Aug 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