SCENARIA View Phase 6.0— 510(k) K261229
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K261229 for SCENARIA View Phase 6.0, Substantially Equivalent on 2026-09-18. Applicant: Fujifilm Corporation. Device class: 2.
Summary
SCENARIA View Phase 6.0 is from Fujifilm Corporation, filed under product code JAK (System, X-Ray, Tomography, Computed). The record gives the name and nothing more about the system.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Fujifilm filed from Minato-Ku, Japan. The decision came 156 calendar days after FDA received it (April 15 to September 18, 2026).
Clearance details
- Applicant
- Fujifilm Corporation
- 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
- Minato-Ku, JP
Recent devices under product code JAK
view allMore clearances from Fujifilm 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.