The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ct Max, Catalog No. B7940 Ha.
| Device ID | K862317 |
| 510k Number | K862317 |
| Device Name: | CT MAX, CATALOG NO. B7940 HA |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | James M Howard |
| Correspondent | James M Howard GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-18 |
| Decision Date | 1986-10-07 |