The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Cer 20/20, Computed Equal Radio Diag Chest.
| Device ID | K913757 |
| 510k Number | K913757 |
| Device Name: | HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST |
| Classification | System, X-ray, Stationary |
| Applicant | HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Contact | Aitkenhead |
| Correspondent | Aitkenhead HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-21 |
| Decision Date | 1991-10-30 |