Cleared Traditional

PSF-50ET (K910850) - FDA 510(k) Clearance

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

K910850 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 64
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K910850.
HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM
K922184 · Hewlett-Packard Co. · Jul 1992
SONOS 100 ULTRASOUND IMAGING SYSTEM
K921036 · Hewlett-Packard Co. · May 1992
LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
K913472 · Baxter Healthcare Corp · Mar 1992
SONICATH(TM) 9F, 12 MHZ
K902245 · Boston Scientific Corp · Oct 1990
RADIUS AND SONOCHROME
K902070 · General Electric Co. · Aug 1990
SIEMENS ENDO-P-PROBE
K897098 · Siemens Medical Solutions USA, Inc. · Feb 1990