Cleared Traditional

K920906 - DGH-500 PACHYMETER

K920906 is the FDA 510(k) clearance for DGH-500 PACHYMETER by Dgh Technology, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K920906 · Dgh Technology, Inc. · Radiology device
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Nov 1992
Decision
249d
Days
Class 2
Risk

K920906 is an FDA 510(k) clearance for the DGH-500 PACHYMETER. 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 November 2, 1992 after a review of 249 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 Dgh Technology, Inc. devices

Submission Details

510(k) Number K920906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1992
Decision Date November 02, 1992
Days to Decision 249 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 107d · This submission: 249d
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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