The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Combison 530d/voluson 530d, Tissue Harmonic Imaging (thi) Option.
| Device ID | K993517 |
| 510k Number | K993517 |
| Device Name: | COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Contact | Gary J Allsebrook |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-10-18 |
| Decision Date | 1999-11-02 |
| Summary: | summary |