MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER— 510(k) K013722
Substantially EquivalentHitachi Medical Corp.
FDA 510(k) clearance K013722 for MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER, Substantially Equivalent on 2002-02-11. Applicant: Hitachi Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Hitachi Medical Corp.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tarrytown, NY, US
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More clearances from Hitachi Medical Corp.
view all- K073310 — OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
- K061608 — MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
- K053258 — EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
- K042501 — ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
- K013723 — MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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.