K022565 is an FDA 510(k) clearance for the TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on October 8, 2002, 67 days after receiving the submission on August 2, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K022565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2002 |
| Decision Date | October 08, 2002 |
| Days to Decision | 67 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |