The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Lightspeed 5.0 Computed Tomography System.
Device ID | K030420 |
510k Number | K030420 |
Device Name: | LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM |
Classification | System, X-ray, Tomography, Computed |
Applicant | GE MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. Waukesha, WI 53188 |
Contact | John W Jaeckle |
Correspondent | John W Jaeckle GE MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. Waukesha, WI 53188 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-10 |
Decision Date | 2003-03-10 |
Summary: | summary |