The following data is part of a premarket notification filed by Instrumentarium Corp. Imaging Division with the FDA for Performa Stereo.
| Device ID | K023864 |
| 510k Number | K023864 |
| Device Name: | PERFORMA STEREO |
| Classification | System, X-ray, Mammographic |
| Applicant | INSTRUMENTARIUM CORP. IMAGING DIVISION 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
| Contact | Brian Broncatti |
| Correspondent | Brian Broncatti INSTRUMENTARIUM CORP. IMAGING DIVISION 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-20 |
| Decision Date | 2003-01-09 |
| Summary: | summary |