The following data is part of a premarket notification filed by General Electric Co. with the FDA for Scpu X-ray Generator.
| Device ID | K940227 |
| 510k Number | K940227 |
| Device Name: | SCPU X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger,ph.d |
| Correspondent | Larry A Kroger,ph.d GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-18 |
| Decision Date | 1994-04-28 |