Processor VP-7000, Light Source BL-7000
FDA 510(k) K163675 · Fujifilm Medical System U.S.A., Inc.
510(k) numberK163675
Submission
- Device name
- Processor VP-7000, Light Source BL-7000
- Applicant
- Fujifilm Medical System U.S.A., Inc.
Wayne, NJ, US - Received
- December 27, 2016
- Decision date
- April 25, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
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| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F)FET · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 02/07/2025SE |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)FET · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 10/22/2024SE |
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| K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFDS · Traditional | 05/14/2015SE |
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Questions and answers
When was Processor VP-7000, Light Source BL-7000 cleared by the FDA?
Processor VP-7000, Light Source BL-7000 (K163675) received a 510(k) decision of Substantially Equivalent on April 25, 2017, 119 days after the submission was received.
What is the product code of K163675?
The FDA product code is FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.