The following data is part of a premarket notification filed by Midmark with the FDA for Progeny Vantage Panoramic X-ray System.
Device ID | K091866 |
510k Number | K091866 |
Device Name: | PROGENY VANTAGE PANORAMIC X-RAY SYSTEM |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | MIDMARK 675 HEATHROW DR. Lincolnshire, IL 60069 |
Contact | Alan Krema |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2009-06-24 |
Decision Date | 2009-07-20 |
Summary: | summary |