Cleared Traditional

LINEAR ARRAY PROBE PLB-310M FOR SAL-32B (K853311) - FDA 510(k) Clearance

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

K853311 · Toshiba Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
98d
Days
Class 2
Risk

K853311 is an FDA 510(k) clearance for the LINEAR ARRAY PROBE PLB-310M FOR SAL-32B. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Medical Systems devices

Submission Details

510(k) Number K853311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1985
Decision Date November 13, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 205
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K853311.
SONOLINE LX
K853946 · Siemens Medical Solutions USA, Inc. · Jan 1986
SONOLINE SL-2(ULTRASOUND SCANNER)
K853008 · Siemens Medical Solutions USA, Inc. · Jan 1986
HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A
K854135 · Hewlett-Packard Co. · Dec 1985
UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52
K852362 · Johnson & Johnson Professionals, Inc. · Oct 1985
RT2600(115V)(220/240V) #H4008A & H4008AE
K851807 · General Electric Co. · Sep 1985
5.0 MHZ LINEAR ARRAY, MODEL 83, 39, 517
K852570 · Siemens Medical Solutions USA, Inc. · Sep 1985