The following data is part of a premarket notification filed by Sigma Biomedics, Inc. with the FDA for Bio-ray Sdx Digital X-ray System.
| Device ID | K060179 |
| 510k Number | K060179 |
| Device Name: | BIO-RAY SDX DIGITAL X-RAY SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SIGMA BIOMEDICS, INC. 65 E. PALATINE RD. #201 Prospect Heights, IL 60070 |
| Contact | Kim Antol |
| Correspondent | Kim Antol SIGMA BIOMEDICS, INC. 65 E. PALATINE RD. #201 Prospect Heights, IL 60070 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-23 |
| Decision Date | 2006-02-08 |
| Summary: | summary |