AQUILION PREMIUM— 510(k) K120546
Substantially EquivalentToshiba Medical Systems Corporation, Japan
FDA 510(k) clearance K120546 for AQUILION PREMIUM, Substantially Equivalent on 2012-06-13. Applicant: Toshiba Medical Systems Corporation, Japan. Device class: 2.
Clearance details
- Applicant
- Toshiba Medical Systems Corporation, Japan
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tustin, CA, US
Recent devices under product code JAK
view allMore clearances from Toshiba Medical Systems Corporation, Japan
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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 K120546
K-number listed on FDA's recall record- Z-1721-2020 — Canon Aquilion Premium, Model TSX-301B
- Z-0015-2016 — Toshiba Aquilion CT System TSX-301B
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120546.
Data sourced from openFDA. This site is unofficial and independent of the FDA.