Cleared Traditional

K905152 - REMOTE CONTROLLED X-RAY DIAG. RSZ-200

K905152 is the FDA 510(k) clearance for REMOTE CONTROLLED X-RAY DIAG. RSZ-200 by Shimadzu Medical Systems. It is a Class 2 Radiology device (product code IXR) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K905152 · Shimadzu Medical Systems · Radiology device
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Dec 1990
Decision
26d
Days
Class 2
Risk

K905152 is an FDA 510(k) clearance for the REMOTE CONTROLLED X-RAY DIAG. RSZ-200. 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 December 11, 1990 after a review of 26 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shimadzu Medical Systems devices

Submission Details

510(k) Number K905152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date December 11, 1990
Days to Decision 26 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
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 K905152.
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004
K911267 · Tri W-G, Inc. · Apr 1991
620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
K905265 · Tri W-G, Inc. · Jan 1991
ELITE 5000
K905501 · Fischer Imaging Corp. · Jan 1991
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
K905153 · Shimadzu Medical Systems · Dec 1990
RMS 180
K893673 · Fischer Imaging Corp. · Jul 1989
GENESIS 180
K883863 · Fischer Imaging Corp. · Oct 1988