The following data is part of a premarket notification filed by Ralco S.r.l. with the FDA for Model R302dacs/a Automatic X-ray Collimator.
Device ID | K072780 |
510k Number | K072780 |
Device Name: | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR |
Classification | Collimator, Automatic, Radiographic |
Applicant | RALCO S.R.L. P.O. BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm RALCO S.R.L. P.O. BOX 7007 Deerfield, IL 60015 |
Product Code | IZW |
CFR Regulation Number | 892.1610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-28 |
Decision Date | 2007-11-26 |
Summary: | summary |