The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Ge 1.5t And 3.0t Signa Hdx Mr System.
| Device ID | K052293 |
| 510k Number | K052293 |
| Device Name: | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS, LLC P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger, Ph.d. |
| Correspondent | Larry A Kroger, Ph.d. GE MEDICAL SYSTEMS, LLC P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-23 |
| Decision Date | 2005-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118941 | K052293 | 000 |
| 00840682116114 | K052293 | 000 |