The following data is part of a premarket notification filed by Almen Laboratories, Inc. with the FDA for Bi-rads Companion.
| Device ID | K072258 |
| 510k Number | K072258 |
| Device Name: | BI-RADS COMPANION |
| Classification | System, Image Processing, Radiological |
| Applicant | ALMEN LABORATORIES, INC. 6319 MASSACHUSETTS AVENUE Bethesda, MD 20816 -1139 |
| Contact | Roger H Schneider |
| Correspondent | Roger H Schneider ALMEN LABORATORIES, INC. 6319 MASSACHUSETTS AVENUE Bethesda, MD 20816 -1139 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-14 |
| Decision Date | 2008-05-16 |
| Summary: | summary |