SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES— 510(k) K001517
Substantially EquivalentShimadzu Corp.
FDA 510(k) clearance K001517 for SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES, Substantially Equivalent on 2000-06-27. 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
- Abbreviated
- Location
- Torrance, CA, US
Recent devices under product code IZL
view allMore clearances from Shimadzu Corp.
view allAdverse 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 K001517
K-number listed on FDA's recall record- Z-1150-2014 — Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
- Z-0262-2013 — 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001517.
Data sourced from openFDA. This site is unofficial and independent of the FDA.