CAS-One IR— 510(k) K261225
Substantially EquivalentCascination AG
FDA 510(k) clearance K261225 for CAS-One IR, Substantially Equivalent on 2026-09-29. Applicant: Cascination AG. Device class: 2.
Summary
CAS-One IR from Cascination AG is filed under JAK, computed tomography X-ray systems. The record doesn't describe what the system does or how it relates to CT imaging beyond that code assignment, and it doesn't expand "IR."
Class II, 21 CFR 892.1750. The Radiology panel reviewed it as a Traditional 510(k).
Cascination filed from Bern, Switzerland. The clock ran 167 days (April 15 to September 29, 2026).
Clearance details
- Applicant
- Cascination AG
- Product code
- Product 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
- Bern, CH
Recent devices under product code JAK
view allMore clearances from Cascination AG
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.