The following data is part of a premarket notification filed by Biosound Esaote, Inc. with the FDA for Au6 (technos/technos Mp) Ultrasound Imaging System (addition Of 3d Imaging Mode And Musculoskeletal Indication).
| Device ID | K014168 |
| 510k Number | K014168 |
| Device Name: | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Colleen H Densmore |
| Correspondent | Colleen H Densmore BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-19 |
| Decision Date | 2002-04-25 |
| Summary: | summary |