Cleared Traditional

TOMAX ULTRASCAN (K892653) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K892653 · Incubation Industries, Inc. · Radiology device
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Aug 1989
Decision
137d
Days
Class 2
Risk

K892653 is an FDA 510(k) clearance for the TOMAX ULTRASCAN. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Incubation Industries, Inc. (Gwynedd, US). The FDA issued a Cleared decision on August 28, 1989 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - 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 Incubation Industries, Inc. devices

Submission Details

510(k) Number K892653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date August 28, 1989
Days to Decision 137 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 107d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
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 - IZF System, X-ray, Tomographic

All 13
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K892653.
DR 600 with Tomosynthesis
K193262 · Agfa N.V. · Mar 2020
DR 800 with Tomosynthesis
K183275 · Agfa N.V. · Feb 2019
TOMO-LINK
K944967 · GE Medical Systems · Dec 1994
CLINIX-R TOMOGRAPHIC DEVICE
K810274 · Philips Medical Systems (Cleveland), Inc. · Mar 1981
VTX (GE CATAOLG NO. B7005A)
K792067 · General Electric Co. · Dec 1979
ORBITOME-UG
K780319 · Philips Medical Systems (Cleveland), Inc. · Mar 1978