The following data is part of a premarket notification filed by Panoramic Corp. with the FDA for Panoramic Corporation Hdlx.
| Device ID | K943532 |
| 510k Number | K943532 |
| Device Name: | PANORAMIC CORPORATION HDLX |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | PANORAMIC CORP. 4321 GOSHEN RD. Fort Wayne, IN 46818 |
| Contact | Mark Smith |
| Correspondent | Mark Smith PANORAMIC CORP. 4321 GOSHEN RD. Fort Wayne, IN 46818 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-21 |
| Decision Date | 1994-12-07 |