Video System Center
FDA 510(k) K122831 · Olympus Medical Systems Corp.
510(k) numberK122831
Submission
- Device name
- Video System Center
- Applicant
- Olympus Medical Systems Corp.
Center Valley, PA, US - Received
- September 17, 2012
- Decision date
- December 14, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NTN – Led Light Source
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
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| K091829 | PLS Portable Light SourceNTN · Abbreviated | Optim, Inc. | 07/28/2009SE |
| K090601 | FSC 2NTN · Traditional | Schoelly Imaging, Inc. | 05/11/2009SE |
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Questions and answers
When was Video System Center cleared by the FDA?
Video System Center (K122831) received a 510(k) decision of Substantially Equivalent on December 14, 2012, 88 days after the submission was received.
What is the product code of K122831?
The FDA product code is NTN – Led Light Source, a Class II (moderate risk) device regulated under 21 CFR 876.1500.