FCT iSTREAM Phase 1
K-Number: K233583 · 2024-04-26
Decision Date2024-04-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FCT iSTREAM Phase 1 is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-04-26 under approval number K233583. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FCT iSTREAM Phase 1?
FCT iSTREAM Phase 1 is a medical device that received FDA 510(k) clearance on 2024-04-26. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233583.
When was FCT iSTREAM Phase 1 approved by the FDA?
FCT iSTREAM Phase 1 received FDA 510(k) clearance on 2024-04-26, under approval number K233583.
What company makes FCT iSTREAM Phase 1?
FCT iSTREAM Phase 1 is manufactured by FUJIFILM Healthcare Americas Corporation.
What is the FDA product code for FCT iSTREAM Phase 1?
The FDA product code for FCT iSTREAM Phase 1 is JAK.
Other Devices by FUJIFILM Healthcare Americas Corporation
K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
K231941ARIETTA x10
K231574Scenaria View 4.2
K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214C
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.