HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)— 510(k) K964990
Substantially EquivalentHitachi Medical Systems America, Inc.
FDA 510(k) clearance K964990 for HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30), Substantially Equivalent on 1997-02-26. Applicant: Hitachi Medical Systems America, Inc.. Device class: 2.
Clearance details
- Applicant
- Hitachi Medical Systems America, Inc.
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code JAA
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view allAdverse 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 →
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