The following data is part of a premarket notification filed by Control-x Medical, Inc. with the FDA for Z-motion Digital Diagnostic X-ray System.
Device ID | K102680 |
510k Number | K102680 |
Device Name: | Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM |
Classification | System, X-ray, Stationary |
Applicant | CONTROL-X MEDICAL, INC. 1755 ATLAS ST. Columbus, OH 43228 |
Contact | Laszlo Adrovitz |
Correspondent | Laszlo Adrovitz CONTROL-X MEDICAL, INC. 1755 ATLAS ST. Columbus, OH 43228 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-17 |
Decision Date | 2010-10-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05999116186126 | K102680 | 000 |