The following data is part of a premarket notification filed by Xre Corp. with the FDA for Full Frame Zoom System.
| Device ID | K961193 |
| 510k Number | K961193 |
| Device Name: | FULL FRAME ZOOM SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | XRE CORP. 300 FOSTER ST. Littleton, MA 01460 -2017 |
| Contact | Wayne V Loomer |
| Correspondent | Wayne V Loomer XRE CORP. 300 FOSTER ST. Littleton, MA 01460 -2017 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1996-06-17 |