PC/QCT QUANTITATIVE SOFTWARE— 510(k) K896677
Substantially EquivalentThe Institute For Radiological Image Sciences, Inc.
FDA 510(k) clearance K896677 for PC/QCT QUANTITATIVE SOFTWARE, Substantially Equivalent on 1990-01-23. Applicant: The Institute For Radiological Image Sciences, Inc..
Clearance details
- Applicant
- The Institute For Radiological Image Sciences, Inc.
- Product code
- Code KGI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Germantown, MD, US
Adverse events under product code KGI
product code KGI- 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.