Cleared Traditional

K934005 - SHIMADZU CEILING TUBE SUPPORT CH-30GX

K934005 is the FDA 510(k) clearance for SHIMADZU CEILING TUBE SUPPORT CH-30GX by Shimadzu Corp.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K934005 · Shimadzu Corp. · Radiology device
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Nov 1993
Decision
98d
Days
Class 2
Risk

K934005 is an FDA 510(k) clearance for the SHIMADZU CEILING TUBE SUPPORT CH-30GX. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Shimadzu Corp. (Gardena, US). The FDA issued a Cleared decision on November 24, 1993 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 892.1680 - 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 K934005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1993
Decision Date November 24, 1993
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K934005.
PHILIPS THORAVISION
K931071 · Philips Medical Systems, Inc. · Sep 1994
BUCKY STAND BR-10M
K942792 · Shimadzu Corp. · Jul 1994
DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR
K941931 · Victoreen, Inc. · May 1994
FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK
K921112 · Fujifilm Medical System U.S.A., Inc. · Apr 1993
HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
K913757 · Hologic, Inc. · Oct 1991
MEDRAD OMNIPLANE 300 SYSTEM
K883834 · Medrad, Inc. · Nov 1988