Cleared Traditional

K872726 - DGH-3000A A-SCAN

K872726 is the FDA 510(k) clearance for DGH-3000A A-SCAN by Dgh Technology, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K872726 · Dgh Technology, Inc. · Radiology device
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Dec 1987
Decision
149d
Days
Class 2
Risk

K872726 is an FDA 510(k) clearance for the DGH-3000A A-SCAN. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Dgh Technology, Inc. (Frazer, US). The FDA issued a Cleared decision on December 4, 1987 after a review of 149 days - within the typical 510(k) review window.

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 Dgh Technology, Inc. devices

Submission Details

510(k) Number K872726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1987
Decision Date December 04, 1987
Days to Decision 149 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 107d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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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