Cleared Traditional

K915138 - GE SONOCHROME

K915138 is an FDA 510(k) clearance for GE SONOCHROME, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code MAA cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K915138 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
342d
Days
Class 2
Risk

K915138 is an FDA 510(k) clearance for the GE SONOCHROME. Classified as Monitor, Fetal Doppler Ultrasound (product code MAA), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on October 20, 1992 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - the FDA radiology and imaging software oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Medical Systems devices

FDA 510(k) Submission Details - K915138

510(k) Number K915138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1991
Decision Date October 20, 1992
Days to Decision 342 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 107d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAA Device Classification - Class 2, Special Controls

Product Code MAA Monitor, Fetal Doppler Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 Radiology devices follow this clearance model.

Regulatory Peers - MAA Monitor, Fetal Doppler Ultrasound

Devices cleared under the same product code (MAA) and FDA review panel - the closest regulatory comparables to K915138.
ULTRASONIC TABLETOP DOPPLER
K102138 · Edan Instruments, Inc. · Oct 2010
FETAL DOPPLER
K905536 · Toshiba America Medical Systems, In.C · Apr 1992
L582 TRANSDUCER
K904600 · Acuson Corp. · Jun 1991
L328 TRANSDUCER
K905456 · Acuson Corp. · May 1991
S5192R TRANSDUCER
K904951 · Acuson Corp. · Apr 1991
SONICAID MODEL VASOFLO 4
K895909 · Oxford Medilog, Inc. · Jul 1990