Cleared Traditional

K873845 - SIM 4000I

K873845 is an FDA 510(k) clearance for SIM 4000I, manufactured by Ote-Biomedica Elettronica S.P.A. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K873845 · Ote-Biomedica Elettronica S.P.A · Radiology device
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Apr 1988
Decision
198d
Days
Class 2
Risk

K873845 is an FDA 510(k) clearance for the SIM 4000I. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ote-Biomedica Elettronica S.P.A (Cambridge, US). The FDA issued a Cleared decision on April 7, 1988 after a review of 198 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Ote-Biomedica Elettronica S.P.A devices

FDA 510(k) Submission Details - K873845

510(k) Number K873845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1987
Decision Date April 07, 1988
Days to Decision 198 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 107d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

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