The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Pegasus Lateral Cardiac Positioner.
| Device ID | K915592 |
| 510k Number | K915592 |
| Device Name: | PEGASUS LATERAL CARDIAC POSITIONER |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | James Morgan |
| Correspondent | James Morgan 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 | 1991-12-13 |
| Decision Date | 1992-01-13 |