SCENARIA View Phase 5.0
FDA 510(k) K250370 · Fujifilm Corporation
510(k) numberK250370
Submission
- Device name
- SCENARIA View Phase 5.0
- Applicant
- Fujifilm Corporation
Minato-Ku, JP - Received
- February 10, 2025
- Decision date
- May 20, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAK
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| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
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| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
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| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | 06/16/2026SE |
| K254075 | Synapse Lung Nodule AIOEB · Traditional | 05/27/2026SE |
| K254189 | Synapse 3D Base Tools (V7.2)QIH · Traditional | 04/30/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | 04/06/2026SE |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…FDT · Traditional | 03/09/2026SE |
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Questions and answers
When was SCENARIA View Phase 5.0 cleared by the FDA?
SCENARIA View Phase 5.0 (K250370) received a 510(k) decision of Substantially Equivalent on May 20, 2025, 99 days after the submission was received.
What is the product code of K250370?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.