The following data is part of a premarket notification filed by X-cel X-ray Corp. with the FDA for Idx-60 Intraoral X-ray.
| Device ID | K993958 |
| 510k Number | K993958 |
| Device Name: | IDX-60 INTRAORAL X-RAY |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | X-CEL X-RAY CORP. 4220 WALLER DR., P.O. BOX 1857 Crystal Lake, IL 60039 -1857 |
| Contact | William W Morris |
| Correspondent | William W Morris X-CEL X-RAY CORP. 4220 WALLER DR., P.O. BOX 1857 Crystal Lake, IL 60039 -1857 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-22 |
| Decision Date | 2000-02-14 |