SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES— 510(k) K041763

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K041763 for SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES, Substantially Equivalent on 2004-07-13. Applicant: Shimadzu Corp.. Device class: 2.

Clearance details

Applicant
Shimadzu Corp.
Product code
Code IZL
Device class
Class 2
Regulation
21 CFR 892.1720
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Torrance, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IZL

product code IZL
Other
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K041763

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041763.

Data sourced from openFDA. This site is unofficial and independent of the FDA.