X-RAY SYSTEM XR-MX— 510(k) K004037
Substantially EquivalentKarl Storz Endoscopy
FDA 510(k) clearance K004037 for X-RAY SYSTEM XR-MX, Substantially Equivalent on 2001-02-02. Applicant: Karl Storz Endoscopy. Device class: 2.
Clearance details
- Applicant
- Karl Storz Endoscopy
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code JAA
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view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.