Cleared Traditional

K900505 - SONOACE 88 PORTABLE ULTRASOUND SCANNER

K900505 is an FDA 510(k) clearance for SONOACE 88 PORTABLE ULTRASOUND SCANNER, manufactured by Medison Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEM cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K900505 · Medison Co., Ltd. · Obstetrics & Gynecology device
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Aug 1990
Decision
189d
Days
Class 2
Risk

K900505 is an FDA 510(k) clearance for the SONOACE 88 PORTABLE ULTRASOUND SCANNER. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by Medison Co., Ltd. (Media, US). The FDA issued a Cleared decision on August 10, 1990 after a review of 189 days - an extended review 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: 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 Medison Co., Ltd. devices

FDA 510(k) Submission Details - K900505

510(k) Number K900505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1990
Decision Date August 10, 1990
Days to Decision 189 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
29d slower than avg
Panel avg: 160d · This submission: 189d
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 K900505.
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
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EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
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FETAL DOPPLER FOR ULTRAMARK 4 AND 8
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SIEMENS INTRAVAGINAL TRANSDUCER
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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