The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Brainstat Software Option For Ge Signa Mr Scanner.
Device ID | K073167 |
510k Number | K073167 |
Device Name: | BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
Correspondent | Yamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-11-09 |
Decision Date | 2008-01-04 |
Summary: | summary |