The following data is part of a premarket notification filed by Huestis Machine Corp. with the FDA for The Huestis Compu-plotter.
| Device ID | K901567 |
| 510k Number | K901567 |
| Device Name: | THE HUESTIS COMPU-PLOTTER |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | HUESTIS MACHINE CORP. 68 BUTTONWOOD ST. Bristol, RI 02809 |
| Contact | Terry Chwalk |
| Correspondent | Terry Chwalk HUESTIS MACHINE CORP. 68 BUTTONWOOD ST. Bristol, RI 02809 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-03 |
| Decision Date | 1990-05-31 |