The following data is part of a premarket notification filed by U-systems, Inc. with the FDA for Full Field Breast Imaging (ffbu) Diagnostic Ultrasound System.
| Device ID | K032640 |
| 510k Number | K032640 |
| Device Name: | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | U-SYSTEMS, INC. 2081 LONGDEN CIRCLE Los Altos,, CA 94204 |
| Contact | Sheila W Pickering |
| Correspondent | Heinz-joerg Steneberg 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-08-27 |
| Decision Date | 2003-09-11 |
| Summary: | summary |