Cleared Traditional

K910850 - PSF-50ET

K910850 is the FDA 510(k) clearance for PSF-50ET by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K910850 · Toshiba America Medical Systems, In.C · Radiology device
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Jan 1992
Decision
336d
Days
Class 2
Risk

K910850 is an FDA 510(k) clearance for the PSF-50ET. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on January 29, 1992 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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. Elevated predicate reliance profile. 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 K910850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1991
Decision Date January 29, 1992
Days to Decision 336 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
229d slower than avg
Panel avg: 107d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 188
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K910850.
SONOLAYER ALPHA, MODEL SSH-140A
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CW DOPPLER 2.25 MHZ PROBE
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BIOPSY ACCESSORIES FOR ULTRASOUND PROBES
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ACUSON V510 TRANSDUCER
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ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3
K912363 · Hitachi Medical Corp. of America · Aug 1991