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 |