INFX-8000H, INFINIX-I— 510(k) K082830
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K082830 for INFX-8000H, INFINIX-I, Substantially Equivalent on 2008-10-10. Applicant: Toshiba America Medical Systems, In.C. Device class: 2.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- 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
- Tustin, CA, US
Recent devices under product code JAA
view allMore clearances from Toshiba America Medical Systems, In.C
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 →
Recalls naming K082830
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082830.
Data sourced from openFDA. This site is unofficial and independent of the FDA.