FCT iSTREAM Phase 1
FDA 510(k) K233583 · FUJIFILM Healthcare Americas Corporation
510(k) numberK233583
Submission
- Device name
- FCT iSTREAM Phase 1
- Applicant
- FUJIFILM Healthcare Americas Corporation
Lexington, MA, US - Received
- November 7, 2023
- Decision date
- April 26, 2024
- 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 |
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| K251204 | FUJIFILM Stiffening Wire Device (SW-2000)FDA · Traditional | 09/26/2025SE |
| K243647 | Synapse PACS (7.5)QIH · Traditional | 06/30/2025SE |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214CFDA · Traditional | 06/13/2024SE |
| K233629 | APERTO Lucent MRI SystemLNH · Traditional | 05/10/2024SE |
| K233687 | ECHELON Synergy V10.0LNH · Traditional | 05/03/2024SE |
| K240075 | FUJIFILM Endoscope Model EB-710XTEOQ · Special | 02/07/2024SE |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)ITX · Traditional | 12/13/2023SE |
| K231941 | ARIETTA x10IYN · Traditional | 11/20/2023SE |
| K231574 | Scenaria View 4.2JAK · Traditional | 10/12/2023SE |
Questions and answers
When was FCT iSTREAM Phase 1 cleared by the FDA?
FCT iSTREAM Phase 1 (K233583) received a 510(k) decision of Substantially Equivalent on April 26, 2024, 171 days after the submission was received.
What is the product code of K233583?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.