The following data is part of a premarket notification filed by Acuson Corp. with the FDA for 3d Organ Assessment W/ Magnetic Position Sensing.
| Device ID | K002807 |
| 510k Number | K002807 |
| Device Name: | 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
| Contact | Chalon Green |
| Correspondent | Chalon Green ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-08 |
| Decision Date | 2000-12-01 |