The following data is part of a premarket notification filed by Medical Imaging Solutions, Inc. with the FDA for New Brid.
| Device ID | K041780 |
| 510k Number | K041780 |
| Device Name: | NEW BRID |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | MEDICAL IMAGING SOLUTIONS, INC. 800 CENTRAL AVE. Jefferson, LA 70121 |
| Contact | Nancy Butcher |
| Correspondent | Nancy Butcher MEDICAL IMAGING SOLUTIONS, INC. 800 CENTRAL AVE. Jefferson, LA 70121 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-01 |
| Decision Date | 2004-08-11 |
| Summary: | summary |