The following data is part of a premarket notification filed by Icad, Inc. with the FDA for Icad Breast Interventional Planning Software, Model D70024.
| Device ID | K090223 |
| 510k Number | K090223 |
| Device Name: | ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 |
| Classification | System, Image Processing, Radiological |
| Applicant | ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 Nashua, NH 03062 |
| Contact | John A Delucia |
| Correspondent | John A Delucia ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 Nashua, NH 03062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-30 |
| Decision Date | 2009-03-31 |
| Summary: | summary |