The following data is part of a premarket notification filed by U-systems, Inc. with the FDA for Automated Breast Ultrasound System, Model Abus.
| Device ID | K052355 |
| 510k Number | K052355 |
| Device Name: | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | U-SYSTEMS, INC. 110 ROSE ORCHARD WAY San Jose, CA 95134 |
| Contact | Robert F Lawrence |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-29 |
| Decision Date | 2005-09-14 |
| Summary: | summary |