Submission Details
| 510(k) Number | K132524 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 2013 |
| Decision Date | June 13, 2014 |
| Days to Decision | 305 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
Jun 2014
Decision
305d
Days
Class 2
Risk
About This 510(k) Submission
K132524 is an FDA 510(k) clearance for the CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Philips Medical Systems (Cleveland, US). The FDA issued a Cleared decision on June 13, 2014, 305 days after receiving the submission on August 12, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.
Device Classification
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1750 |
Manufacturer
Similar Devices — JAK System, X-ray, Tomography, Computed
All 811
K252249 · Mars Bioimaging , Ltd.
· Mar 2026
K260078 · Canon Medical Systems Corporation
· Mar 2026
K260166 · BunkerHill Health
· Mar 2026
K260167 · BunkerHill Health
· Mar 2026
K260169 · Philips Medical Systems Nederland B.V.
· Mar 2026
K253173 · Shanghai United Imaging Healthcare Co., Ltd.
· Jan 2026
More from Philips Medical Systems
View all
K212704
· IYN · Sep 2021
K211597
· IYN · Sep 2021
K210560
· DPS · Jun 2021
K191738
· DPS · Sep 2020
K192875
· DRG · Apr 2020