PowerDR— 510(k) K191504
Substantially EquivalentRadiology Information Systems, Inc.
FDA 510(k) clearance K191504 for PowerDR, Substantially Equivalent on 2019-08-16. Applicant: Radiology Information Systems, Inc..
Clearance details
- Applicant
- Radiology Information Systems, Inc.
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dulles, VA, US
Adverse 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.