AQUILION PRIME, V6.00— 510(k) K141741
Substantially EquivalentToshibamedical Systems Corporation
FDA 510(k) clearance K141741 for AQUILION PRIME, V6.00, Substantially Equivalent on 2014-11-26. Applicant: Toshibamedical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Toshibamedical Systems Corporation
- 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 Toshibamedical Systems Corporation
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 K141741
K-number listed on FDA's recall record- Z-0622-2017 — Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
- Z-0018-2016 — Toshiba Aquilion CT System TSX-303A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141741.
Data sourced from openFDA. This site is unofficial and independent of the FDA.