The following data is part of a premarket notification filed by X-cel X-ray Corp. with the FDA for X-cel X-ray Models Ort90w, Ort90m And Ort90r.
| Device ID | K871116 |
| 510k Number | K871116 |
| Device Name: | X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R |
| Classification | Generator, Dermatological (grenz Ray), Therapeutic X-ray |
| 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 | IYH |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-19 |
| Decision Date | 1987-05-14 |