The following data is part of a premarket notification filed by Schiff Photo Mechanics with the FDA for Instant Imager.
| Device ID | K833228 |
| 510k Number | K833228 |
| Device Name: | INSTANT IMAGER |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SCHIFF PHOTO MECHANICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-25 |
| Decision Date | 1983-10-28 |