The following data is part of a premarket notification filed by Image Diagnostics, Inc. with the FDA for Id100 Mobile Fluoroscopic Examining Table.
| Device ID | K942190 |
| 510k Number | K942190 |
| Device Name: | ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE |
| Classification | Table, Radiographic, Stationary Top |
| 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 | IXQ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-04 |
| Decision Date | 1994-08-17 |