The following data is part of a premarket notification filed by Almana Medical Imaging with the FDA for Rad Vision, Models E And Eu.
Device ID | K072659 |
510k Number | K072659 |
Device Name: | RAD VISION, MODELS E AND EU |
Classification | System, X-ray, Stationary |
Applicant | ALMANA MEDICAL IMAGING PO BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm ALMANA MEDICAL IMAGING PO BOX 7007 Deerfield, IL 60015 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-20 |
Decision Date | 2007-11-15 |
Summary: | summary |