The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Jupiter Processing And Review Workstation.
Device ID | K024137 |
510k Number | K024137 |
Device Name: | JUPITER PROCESSING AND REVIEW WORKSTATION |
Classification | System, Image Processing, Radiological |
Applicant | GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-16 |
Decision Date | 2003-01-15 |
Summary: | summary |