Cleared Traditional

K993674 - POCKET ULTRASONIC PACHYMETER

K993674 is an FDA 510(k) clearance for POCKET ULTRASONIC PACHYMETER, manufactured by Quantel Medical. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K993674 · Quantel Medical · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
255d
Days
Class 2
Risk

K993674 is an FDA 510(k) clearance for the POCKET ULTRASONIC PACHYMETER. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Quantel Medical (Hasbrouck Heights, US). The FDA issued a Cleared decision on July 13, 2000 after a review of 255 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 Quantel Medical devices

FDA 510(k) Submission Details - K993674

510(k) Number K993674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1999
Decision Date July 13, 2000
Days to Decision 255 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 107d · This submission: 255d
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 688
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K993674.
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
K003936 · Tomtec Imaging Systems GmbH · Feb 2001
3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
K002807 · Acuson Corp. · Dec 2000
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
K003121 · Medison America, Inc. · Oct 2000
AU5, AU6
K000681 · Biosound Esaote, Inc. · May 2000
GE LOGIQ 700
K000516 · Ge Medical Systems, Inc. · Apr 2000
GE LOGIQ 700
K000571 · GE Medical Systems · Apr 2000