The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Tethered Portable Digital Radiographic Detector.
| Device ID | K041922 |
| 510k Number | K041922 |
| Device Name: | GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR |
| Classification | System, X-ray, Mobile |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | David Duersteler |
| Correspondent | David Duersteler GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-16 |
| Decision Date | 2004-07-28 |
| Summary: | summary |