Cleared Traditional

K924478 - MTV-250A, MTV-300A

K924478 is an FDA 510(k) clearance for MTV-250A, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K924478 · Toshiba America Medical Systems, In.C · Radiology device
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Optimized for regulatory review, auditing and printing
Dec 1992
Decision
92d
Days
Class 2
Risk

K924478 is an FDA 510(k) clearance for the MTV-250A, MTV-300A. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on December 4, 1992 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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

FDA 510(k) Submission Details - K924478

510(k) Number K924478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1992
Decision Date December 04, 1992
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

All 30
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K924478.
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K874778 · Eastman Kodak Company · Feb 1989