FCT iStream Phase 2
FDA 510(k) K253836 · Fujifilm Corporation
510(k) numberK253836
Submission
- Device name
- FCT iStream Phase 2
- Applicant
- Fujifilm Corporation
Minato-Ku, JP - Received
- December 1, 2025
- Decision date
- September 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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Questions and answers
When was FCT iStream Phase 2 cleared by the FDA?
FCT iStream Phase 2 (K253836) received a 510(k) decision of Substantially Equivalent on September 4, 2026, 277 days after the submission was received.
What is the product code of K253836?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.