The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Dental X-ray Unit W/cephalometric Attach.
| Device ID | K781287 |
| 510k Number | K781287 |
| Device Name: | DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH |
| Classification | Cephalometer |
| Applicant | SIEMENS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EAG |
| CFR Regulation Number | 872.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-26 |
| Decision Date | 1978-09-11 |