AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE— 510(k) K984280
Substantially EquivalentHitachi Medical Systems America, Inc.
FDA 510(k) clearance K984280 for AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE, Substantially Equivalent on 1999-02-08. Applicant: Hitachi Medical Systems America, Inc..
Clearance details
- Applicant
- Hitachi Medical Systems America, Inc.
- Product code
- Code LNH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Twinsburg, OH, US
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
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.