QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES— 510(k) K853217
Substantially EquivalentQuantum Medical Systems, Inc.
FDA 510(k) clearance K853217 for QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES, Substantially Equivalent on 1985-12-30. Applicant: Quantum Medical Systems, Inc..
Clearance details
- Applicant
- Quantum Medical Systems, Inc.
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Issaquah, WA, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.