The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Imagechecker Ct Cad Software System.
| Device ID | K043617 |
| 510k Number | K043617 |
| Device Name: | IMAGECHECKER CT CAD SOFTWARE SYSTEM |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Arthur Friedman |
| Correspondent | Arthur Friedman HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-26 |
| Decision Date | 2007-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260483290121 | K043617 | 000 |
| 04260483290107 | K043617 | 000 |
| 04260483290084 | K043617 | 000 |