Cleared Traditional

K905412 - ES/ULTRA DISPLAY AND PROCESSING STATION

K905412 is the FDA 510(k) clearance for ES/ULTRA DISPLAY AND PROCESSING STATION by Toshiba America Medical Systems, In.C. It is a Class 1 Radiology device (product code IYX) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K905412 · Toshiba America Medical Systems, In.C · Radiology device
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Mar 1991
Decision
112d
Days
Class 1
Risk

K905412 is an FDA 510(k) clearance for the ES/ULTRA DISPLAY AND PROCESSING STATION. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on March 25, 1991 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K905412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1990
Decision Date March 25, 1991
Days to Decision 112 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 107d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 64
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K905412.
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K900689 · Adac Laboratories · Apr 1990