Cleared Traditional

K940294 - SHIMADZU MOBILE X-RAY SYSTEMS

K940294 is an FDA 510(k) clearance for SHIMADZU MOBILE X-RAY SYSTEMS, manufactured by Shimadzu Precision Instruments, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K940294 · Shimadzu Precision Instruments, Inc. · Radiology device
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Mar 1994
Decision
54d
Days
Class 2
Risk

K940294 is an FDA 510(k) clearance for the SHIMADZU MOBILE X-RAY SYSTEMS. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on March 16, 1994 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Precision Instruments, Inc. devices

FDA 510(k) Submission Details - K940294

510(k) Number K940294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date March 16, 1994
Days to Decision 54 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
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
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 - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 36
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