MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM— 510(k) K080211
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K080211 for MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM, Substantially Equivalent on 2008-03-14. Applicant: Toshiba America Medical Systems, In.C. Device class: 2.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- 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
- Traditional
- Location
- Tustin, CA, US
Recent devices under product code JAK
view allMore clearances from Toshiba America Medical Systems, In.C
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 K080211
K-number listed on FDA's recall record- Z-0013-2016 — Toshiba Aquilion CT System TSX-101A
- Z-1113-2014 — TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080211.
Data sourced from openFDA. This site is unofficial and independent of the FDA.