The following data is part of a premarket notification filed by Sitco, Inc. with the FDA for Biopsy-digit.
| Device ID | K990192 |
| 510k Number | K990192 |
| Device Name: | BIOPSY-DIGIT |
| Classification | System, X-ray, Mammographic |
| Applicant | SITCO, INC. 3456 N. RIDGE AVE. #100 Arlington Heights, IL 60004 |
| Contact | Robert H Mccarthy |
| Correspondent | Robert H Mccarthy SITCO, INC. 3456 N. RIDGE AVE. #100 Arlington Heights, IL 60004 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-21 |
| Decision Date | 1999-03-12 |
| Summary: | summary |