Cleared Traditional

K920728 - X-RAY DIAGNOSTIC TABLE YSF-100

K920728 is the FDA 510(k) clearance for X-RAY DIAGNOSTIC TABLE YSF-100 by Shimadzu Medical Systems. It is a Class 2 Radiology device (product code IXR) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K920728 · Shimadzu Medical Systems · Radiology device
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May 1992
Decision
100d
Days
Class 2
Risk

K920728 is an FDA 510(k) clearance for the X-RAY DIAGNOSTIC TABLE YSF-100. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 Medical Systems devices

Submission Details

510(k) Number K920728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1992
Decision Date May 28, 1992
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IXR Table, Radiographic, Tilting

All 33
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K920728.
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
K925175 · Shimadzu Medical Systems · Nov 1992
DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
K922364 · Toshiba America Medical Systems, In.C · Sep 1992
UROLOGICAL X-RAY TABLE HS-10A
K920726 · Shimadzu Medical Systems · May 1992
X-RAY DIAGNOSTIC TABLE YSF-200-30-90
K920722 · Shimadzu Medical Systems · Apr 1992
TANGENT V
K915853 · Fischer Imaging Corp. · Jan 1992
X-RAY TABLE
K914165 · Siemens Medical Solutions USA, Inc. · Nov 1991