The following data is part of a premarket notification filed by Hipgraphics, Inc. with the FDA for Hipgraphics System One W/orthotool.
| Device ID | K894402 |
| 510k Number | K894402 |
| Device Name: | HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL |
| Classification | System, Image Processing, Radiological |
| Applicant | HIPGRAPHICS, INC. POST OFFICE BOX 23028 Baltimore, MD 21203 |
| Contact | Derek R Ney |
| Correspondent | Derek R Ney HIPGRAPHICS, INC. POST OFFICE BOX 23028 Baltimore, MD 21203 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-11-17 |