Cleared Traditional

K910462 - POCKET DOP 3

K910462 is an FDA 510(k) clearance for POCKET DOP 3, manufactured by Imex Medical Systems, Inc.. The device is a Class 2 Radiology device with product code HEP cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K910462 · Imex Medical Systems, Inc. · Radiology device
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Jun 1991
Decision
140d
Days
Class 2
Risk

K910462 is an FDA 510(k) clearance for the POCKET DOP 3. Classified as Monitor, Blood-flow, Ultrasonic (product code HEP), Class II - Special Controls.

Submitted by Imex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 140 days - within the typical 510(k) review window.

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. 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 Imex Medical Systems, Inc. devices

FDA 510(k) Submission Details - K910462

510(k) Number K910462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1991
Decision Date June 24, 1991
Days to Decision 140 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEP Device Classification - Class 2, Special Controls

Product Code HEP Monitor, Blood-flow, Ultrasonic
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.