The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Biopsy Transducer.
| Device ID | K811843 |
| 510k Number | K811843 |
| Device Name: | BIOPSY TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SIEMENS GAMMASONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-08-25 |