The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Delta 16.
| Device ID | K955411 |
| 510k Number | K955411 |
| Device Name: | DELTA 16 |
| Classification | System, X-ray, Mammographic |
| Applicant | INSTRUMENTARIUM IMAGING, INC. P.O. BOX 20 (NAHKELANTIE 160) FIN-04301 Tuusula, Finland, FI |
| Contact | Risto Mynttinen |
| Correspondent | Risto Mynttinen INSTRUMENTARIUM IMAGING, INC. 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 | 1995-11-27 |
| Decision Date | 1996-03-21 |