The following data is part of a premarket notification filed by Endosonics Corp. with the FDA for Cathscanner Visions Microrail Ultra Imag Cath.
| Device ID | K924980 |
| 510k Number | K924980 |
| Device Name: | CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ENDOSONICS CORP. 3078-B PROSPECT PARK DR. Rancho Cordova, CA 95670 |
| Contact | Adam D Savakus |
| Correspondent | Adam D Savakus ENDOSONICS CORP. 3078-B PROSPECT PARK DR. Rancho Cordova, CA 95670 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-01 |
| Decision Date | 1993-01-15 |