FDA 510(k)

Processor VP-7000, Light Source BL-7000

K-Number: K163675 · 2017-04-25

ApplicantFujifilm Medical System U.S.A., Inc.

Decision Date2017-04-25

Product CodeFET

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Processor VP-7000, Light Source BL-7000 is a medical device manufactured by Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2017-04-25 under approval number K163675. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Processor VP-7000, Light Source BL-7000?

Processor VP-7000, Light Source BL-7000 is a medical device that received FDA 510(k) clearance on 2017-04-25. It is manufactured by Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K163675.

When was Processor VP-7000, Light Source BL-7000 approved by the FDA?

Processor VP-7000, Light Source BL-7000 received FDA 510(k) clearance on 2017-04-25, under approval number K163675.

What company makes Processor VP-7000, Light Source BL-7000?

Processor VP-7000, Light Source BL-7000 is manufactured by Fujifilm Medical System U.S.A., Inc..

What is the FDA product code for Processor VP-7000, Light Source BL-7000?

The FDA product code for Processor VP-7000, Light Source BL-7000 is FET.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT05964907 Optimizing Phototesting and Investigating Photobiology of Visible Light ACTIVE_NOT_RECRUITING NCT07557550 Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients RECRUITING NCT05552053 Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women ACTIVE_NOT_RECRUITING

Other Devices by Fujifilm Medical System U.S.A., Inc.

K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

Related Devices (Code: FET)

K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc. K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp. K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc. K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEADRichard Wolf Medical Instruments Corporation K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc.

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.