ATUSA™ Automated 3D Breast Ultrasound System
System, Imaging, Pulsed Echo, Ultrasonic
ISono Health, Inc.
The following data is part of a premarket notification filed by Isono Health, Inc. with the FDA for Atusa™ Automated 3d Breast Ultrasound System.
Pre-market Notification Details
| Device ID | K213620 |
| 510k Number | K213620 |
| Device Name: | ATUSA™ Automated 3D Breast Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | iSono Health, Inc. 395 Oyster Point Blvd., Suite 501 South San Fransisco, CA 94080 |
| Contact | Shadi Saberi |
| Correspondent | Daniel Lehtonen Compliance And Regulatory Services LLC 3771 Southbrook Dr Dayton, OH 45430 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-16 |
| Decision Date | 2022-04-22 |
Trademark Results [ATUSA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ATUSA 88369099 not registered Live/Pending |
ISONO HEALTH, INC. 2019-04-03 |
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