Cleared Traditional

SDL-32 ELECTRONIC LINEAR SCANNER (K850834) - FDA 510(k) Clearance

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

K850834 · Shimadzu Corp. · Radiology device
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Oct 1985
Decision
244d
Days
Class 2
Risk

K850834 is an FDA 510(k) clearance for the SDL-32 ELECTRONIC LINEAR SCANNER. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Shimadzu Corp. (Gardena, US). The FDA issued a Cleared decision on October 31, 1985 after a review of 244 days - an extended review cycle.

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 Shimadzu Corp. devices

Submission Details

510(k) Number K850834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date October 31, 1985
Days to Decision 244 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 107d · This submission: 244d
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 176
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K850834.
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K852362 · Johnson & Johnson Professionals, Inc. · Oct 1985
RT2600(115V)(220/240V) #H4008A & H4008AE
K851807 · General Electric Co. · Sep 1985
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K852570 · Siemens Medical Solutions USA, Inc. · Sep 1985