Cleared Traditional

K992505 - TERATECH

K992505 is an FDA 510(k) clearance for TERATECH, manufactured by Teratech Corp.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K992505 · Teratech Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 1999
Decision
106d
Days
Class 2
Risk

K992505 is an FDA 510(k) clearance for the TERATECH, MODEL 2000 IMAGING IMAGING. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Teratech Corp. (North Attleboro, US). The FDA issued a Cleared decision on November 10, 1999 after a review of 106 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 Teratech Corp. devices

FDA 510(k) Submission Details - K992505

510(k) Number K992505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1999
Decision Date November 10, 1999
Days to Decision 106 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 107d · This submission: 106d
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 490
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K992505.
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K000030 · Medison America, Inc. · Jan 2000
GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION
K993364 · Ge Medical Systems, Inc. · Nov 1999
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K993365 · Ge Medical Systems, Inc. · Nov 1999
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K993394 · Tomtec Imaging Systems GmbH · Nov 1999