The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Telstar Biplane Digital Imaging System [tis] Model 030-000915.
| Device ID | K022565 |
| 510k Number | K022565 |
| Device Name: | TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis, MO 63108 |
| Contact | Peter A Takes |
| Correspondent | Peter A Takes STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis, MO 63108 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-02 |
| Decision Date | 2002-10-08 |
| Summary: | summary |