Vista Illumination System
FDA 510(k) K970217 · Vista Medical Technologies, Inc.
510(k) numberK970217
Submission
- Device name
- Vista Illumination System
- Applicant
- Vista Medical Technologies, Inc.
Westborough, MA, US - Received
- January 21, 1997
- Decision date
- April 2, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFS – Image, Illumination, Fiberoptic, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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|---|---|---|
| K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice Activation…GCJ · Abbreviated | 06/28/2002SE |
| K020301 | Modification to Vista Stereoscope SystemFET · Special | 02/12/2002SE |
| K991303 | Vista Orpc with Infomatix Intraop SoftwareGCJ · Traditional | 07/12/1999SE |
| K990635 | Vista Stereoscope SystemGCJ · Traditional | 05/19/1999SE |
| K973436 | Vista Head Mounted DisplayGCJ · Traditional | 12/09/1997SE |
| K971373 | Vista Single Chip Video CameraFET · Traditional | 05/20/1997SE |
| K961800 | Head Mounted DisplayGCJ · Traditional | 09/11/1996SE |
| K953888 | Telescope 4MM, 2.7MM Diam. Wide Angle 0', 30', 70', 4MM, Diam, 30' Work, L 14CM…EOB · Traditional | 10/07/1995SE |
Questions and answers
When was Vista Illumination System cleared by the FDA?
Vista Illumination System (K970217) received a 510(k) decision of Substantially Equivalent on April 2, 1997, 71 days after the submission was received.
What is the product code of K970217?
The FDA product code is FFS – Image, Illumination, Fiberoptic, For Endoscope , a Class II (moderate risk) device regulated under 21 CFR 876.1500.