Cleared Traditional

K863708 - 7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12

K863708 is an FDA 510(k) clearance for 7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K863708 · Siemens Medical Solutions USA, Inc. · Radiology device
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Mar 1987
Decision
181d
Days
Class 2
Risk

K863708 is an FDA 510(k) clearance for the 7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 23, 1987 after a review of 181 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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. Standard predicate reliance. 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K863708

510(k) Number K863708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date March 23, 1987
Days to Decision 181 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 107d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 324
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K863708.
SONOLAYER - V, SSA-100A.
K863269 · Toshiba Medical Systems · Jul 1987
7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE
K870748 · Philips Ultrasound, Inc. · Apr 1987
TRT TRANS-RECTAL TRANSDUCER
K870038 · Advanced Technology Laboratories, Inc. · Mar 1987
DIASONICS SPA 5.O 27MM PROBE
K864758 · Diasonics, Inc. · Mar 1987
DIASONICS SPA 3.5 MHZ, 30MM PROBE
K864812 · Diasonics, Inc. · Mar 1987
SERIES 620 RECTAL PROBE COVER
K864222 · General Electric Co. · Mar 1987