Cleared Traditional

K904044 - TF-63SA

K904044 is an FDA 510(k) clearance for TF-63SA, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code KPW cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K904044 · Toshiba America Medical Systems, In.C · Radiology device
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Nov 1990
Decision
86d
Days
Class 2
Risk

K904044 is an FDA 510(k) clearance for the TF-63SA. Classified as Device, Beam Limiting, X-ray, Diagnostic (product code KPW), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1610 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K904044

510(k) Number K904044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1990
Decision Date November 29, 1990
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPW Device Classification - Class 2, Special Controls

Product Code KPW Device, Beam Limiting, X-ray, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
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 - KPW Device, Beam Limiting, X-ray, Diagnostic

Devices cleared under the same product code (KPW) and FDA review panel - the closest regulatory comparables to K904044.
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K781984 · Siemens Corp. · Dec 1978