The following data is part of a premarket notification filed by Ge Healthcare (ge Medical Systems Scs) with the FDA for Ready View.
Device ID | K110573 |
510k Number | K110573 |
Device Name: | READY VIEW |
Classification | System, Image Processing, Radiological |
Applicant | GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) 3200 N GRANDVIEW BLVD, W-827 Waukesha, WI 53188 |
Contact | Elizabeth Mathew |
Correspondent | Elizabeth Mathew GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) 3200 N GRANDVIEW BLVD, W-827 Waukesha, WI 53188 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-01 |
Decision Date | 2011-05-03 |
Summary: | summary |