The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Lc Positioner.
| Device ID | K981414 |
| 510k Number | K981414 |
| Device Name: | LC POSITIONER |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Samuel D Emrich |
| Correspondent | Samuel D Emrich FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-20 |
| Decision Date | 1998-07-16 |