Cleared Traditional

K913067 - DGH-4000 A-SCAN/PACHYMETER

K913067 is an FDA 510(k) clearance for DGH-4000 A-SCAN/PACHYMETER, manufactured by Dgh Technology, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K913067 · Dgh Technology, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
204d
Days
Class 2
Risk

K913067 is an FDA 510(k) clearance for the DGH-4000 A-SCAN/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 January 31, 1992 after a review of 204 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

FDA 510(k) Submission Details - K913067

510(k) Number K913067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1991
Decision Date January 31, 1992
Days to Decision 204 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
97d slower than avg
Panel avg: 107d · This submission: 204d
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

All 655
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K913067.
ACUSON IMAGE MANAGEMENT SYSTEM
K921670 · Acuson Corp. · Jun 1992
MAESTRO DIGITAL VIDEO SYSTEM
K920373 · International Imaging Electronics · Jun 1992
ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM
K920374 · Ge Medical Systems Information Technologies · Apr 1992
COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR
K910956 · Storz Instrument Co. · Sep 1991
SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K910342 · Medison Co., Ltd. · Aug 1991
ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)
K903603 · Advanced Technology Laboratories, Inc. · Feb 1991