Cleared Traditional

K810305 - DATASON DB ULTRASOUND IMAGING SYSTEM

K810305 is an FDA 510(k) clearance for DATASON DB ULTRASOUND IMAGING SYSTEM, manufactured by General Electric Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HEM cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K810305 · General Electric Co. · Obstetrics & Gynecology device
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Mar 1981
Decision
36d
Days
Class 2
Risk

K810305 is an FDA 510(k) clearance for the DATASON DB ULTRASOUND IMAGING SYSTEM. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981 after a review of 36 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.

FDA 510(k) Submission Details - K810305

510(k) Number K810305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1981
Decision Date March 13, 1981
Days to Decision 36 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
125d faster than avg
Panel avg: 161d · This submission: 36d
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 29
Devices cleared under the same product code (HEM) and FDA review panel - the closest regulatory comparables to K810305.
GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING
K834088 · Whs Products, Inc. · Dec 1983
SONICOMP
K833488 · Sonicaid, Inc. · Nov 1983
GRAYLINE IMAGING SYSTEM
K811520 · Sonics Research Corp. · Jul 1981
ULTRASONIC IMAGER
K780876 · Air-Shields, Inc. · Jun 1978
ROCHE AXISCAN 5
K771816 · Roche Medical Electronics, Inc. · Oct 1977
ULTRASOUND B-SCANNING SYSTEM
K770644 · Unirad Corp. · Apr 1977
K810305 · DATASON DB ULTRASOUND IMAGING SYSTEM
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