MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM— 510(k) K970964
Substantially EquivalentInternational Imaging Electronics
FDA 510(k) clearance K970964 for MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM, Substantially Equivalent on 1997-06-13. Applicant: International Imaging Electronics.
Clearance details
- Applicant
- International Imaging Electronics
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bolingbrook, IL, US
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.