The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Pathfinder Mobile C Arm.
| Device ID | K981131 |
| 510k Number | K981131 |
| Device Name: | PATHFINDER MOBILE C ARM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Contact | James Lambrecht |
| Correspondent | James Lambrecht ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-30 |
| Decision Date | 1998-06-26 |