CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM— 510(k) K081836
Substantially EquivalentCarestream Health, Inc.
FDA 510(k) clearance K081836 for CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM, Substantially Equivalent on 2008-07-30. Applicant: Carestream Health, Inc..
Clearance details
- Applicant
- Carestream Health, Inc.
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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.