XR-910— 510(k) K981466
Substantially EquivalentImaging Sciences Intl., Inc.
FDA 510(k) clearance K981466 for XR-910, Substantially Equivalent on 1998-07-14. Applicant: Imaging Sciences Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Imaging Sciences Intl., Inc.
- 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
- Roebling, NJ, US
Recent devices under product code IZL
view allMore clearances from Imaging Sciences Intl., Inc.
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.