The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Precision Thunis 800+.
| Device ID | K061028 |
| 510k Number | K061028 |
| Device Name: | PRECISION THUNIS 800+ |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N. GRANDVIEW BLVD. W-440 Waukesha, WI 53188 |
| Contact | Larry Kroger |
| Correspondent | Larry Kroger GE MEDICAL SYSTEMS, LLC 3000 N. GRANDVIEW BLVD. W-440 Waukesha, WI 53188 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-06-07 |
| Summary: | summary |