Cleared Traditional

K972771 - PHASED ARRAY TRANSDUCER - - PVF -375DT

K972771 is the FDA 510(k) clearance for PHASED ARRAY TRANSDUCER - - PVF -375DT 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 202-day FDA review.

K972771 · Toshiba America Medical Systems, In.C · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 1998
Decision
202d
Days
Class 2
Risk

K972771 is an FDA 510(k) clearance for the PHASED ARRAY TRANSDUCER - - PVF -375DT. 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 February 11, 1998 after a review of 202 days - an extended review cycle.

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. 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 K972771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1997
Decision Date February 11, 1998
Days to Decision 202 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
95d slower than avg
Panel avg: 107d · This submission: 202d
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
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