The following data is part of a premarket notification filed by General Electric Co. with the FDA for Radius Cf.
| Device ID | K894547 |
| 510k Number | K894547 |
| Device Name: | RADIUS CF |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Kroger, Phd |
| Correspondent | Kroger, Phd GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-11-22 |