The following data is part of a premarket notification filed by Image Diagnostics, Inc. with the FDA for Id400 Series Armboards.
| Device ID | K950631 |
| 510k Number | K950631 |
| Device Name: | ID400 SERIES ARMBOARDS |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | IMAGE DIAGNOSTICS, INC. 98 PRATTS JUNCTION RD. Sterling, MA 01564 |
| Contact | Remo J Rossi |
| Correspondent | Remo J Rossi IMAGE DIAGNOSTICS, INC. 98 PRATTS JUNCTION RD. Sterling, MA 01564 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-13 |
| Decision Date | 1995-03-24 |