SCENARIA View
FDA 510(k) K213829 · Fujifilm Healthcare Corporation
510(k) numberK213829
Submission
- Device name
- SCENARIA View
- Applicant
- Fujifilm Healthcare Corporation
Kashiwa-Shi, JP - Received
- December 8, 2021
- Decision date
- May 23, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241429 | ECHELON Synergy MRI SystemLNH · Traditional | 08/13/2024SE |
| K240571 | OASIS MRI SystemLNH · Traditional | 04/12/2024SE |
| K223426 | ECHELON Synergy MRI systemLNH · Traditional | 07/13/2023SE |
| K221619 | ECHELON Oval V6.2 MRI SystemLNH · Traditional | 01/26/2023SE |
| K220295 | Arietta 50IYN · Abbreviated | 04/29/2022SE |
Questions and answers
When was SCENARIA View cleared by the FDA?
SCENARIA View (K213829) received a 510(k) decision of Substantially Equivalent on May 23, 2022, 166 days after the submission was received.
What is the product code of K213829?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.