The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Alpha Stereo.
| Device ID | K934478 |
| 510k Number | K934478 |
| Device Name: | ALPHA STEREO |
| Classification | System, X-ray, Mammographic |
| Applicant | INSTRUMENTARIUM CORP. P.O. BOX 20 (NAHKELANTIE 160) FIN-04301 Tuusula, Finland, FI |
| Contact | Risto Mynttinen |
| Correspondent | Risto Mynttinen INSTRUMENTARIUM CORP. P.O. BOX 20 (NAHKELANTIE 160) FIN-04301 Tuusula, Finland, FI |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-14 |
| Decision Date | 1995-01-31 |