The following data is part of a premarket notification filed by Machlett Laboratories, Inc. with the FDA for 1.5` Focal Spot Resolution Pattern.
| Device ID | K810254 |
| 510k Number | K810254 |
| Device Name: | 1.5` FOCAL SPOT RESOLUTION PATTERN |
| Classification | Test-pattern, Radiographic |
| Applicant | MACHLETT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IXF |
| CFR Regulation Number | 892.1940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-30 |
| Decision Date | 1981-02-19 |