VS-100 Illumination and Imaging System
FDA 510(k) K090800 · Schoelly Imaging, Inc.
510(k) numberK090800
Submission
- Device name
- VS-100 Illumination and Imaging System
- Applicant
- Schoelly Imaging, Inc.
Framingham, MA, US - Received
- March 24, 2009
- Decision date
- May 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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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Questions and answers
When was VS-100 Illumination and Imaging System cleared by the FDA?
VS-100 Illumination and Imaging System (K090800) received a 510(k) decision of Substantially Equivalent on May 18, 2009, 55 days after the submission was received.
What is the product code of K090800?
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.