Cleared Abbreviated

SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES (K001517) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K001517 · Shimadzu Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
42d
Days
Class 2
Risk

K001517 is an FDA 510(k) clearance for the SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on June 27, 2000 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Shimadzu Corp. devices

Submission Details

510(k) Number K001517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2000
Decision Date June 27, 2000
Days to Decision 42 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 93
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K001517.
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K071015 · Siemens Medical Solutions USA, Inc. · May 2007
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · General Electric Co. · Jul 2004
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
K022337 · Siemens Medical Solutions USA, Inc. · Aug 2002
MOBILETT PLUS MOBILE X-RAY SYSTEM
K932106 · Siemens Medical Solutions USA, Inc. · Sep 1994
MX MOBILE X-RAY SYSTEM
K862452 · Philips Medical Systems (Cleveland), Inc. · Jul 1986
APR MOBILE
K843192 · Philips Medical Systems (Cleveland), Inc. · Sep 1984