# SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation

**Predicate Speed & CAPA Advisory Opportunity Score:** 42/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261229 |
| Device | SCENARIA View Phase 6.0 |
| Applicant | Fujifilm Corporation |
| Specialty / panel | Radiology |
| Product code | JAK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-15 |
| Decision date | 2026-09-18 |
| Review time (days) | 156 |
| Third-party review | No |
| Applicant location | Minato-Ku, JP |

## Why this score
- 156-day review, longer than typical.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261229). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.