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 | K113456 |
| 510k Number | K113456 |
| Device Name: | READY VIEW |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) 3144 N GRANDVIEW BLVD, MAIL STOP- W-501 Waukesha, WI 53188 |
| Contact | Elizabeth Mathew |
| Correspondent | Elizabeth Mathew GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) 3144 N GRANDVIEW BLVD, MAIL STOP- W-501 Waukesha, WI 53188 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-11-21 |
| Decision Date | 2012-06-15 |
| Summary: | summary |