The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Centricity Universal Viewer Zero Footprint Client.
Device ID | K131977 |
510k Number | K131977 |
Device Name: | CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT |
Classification | System, Image Processing, Radiological |
Applicant | GE HEALTHCARE 540 W. NORTHWEST HIGHWAY Barrington, IL 60010 |
Contact | Nicole Landreville |
Correspondent | Nicole Landreville GE HEALTHCARE 540 W. NORTHWEST HIGHWAY Barrington, IL 60010 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-28 |
Decision Date | 2013-09-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682102988 | K131977 | 000 |