The following data is part of a premarket notification filed by X-cel X-ray Corp. with the FDA for X-cell X-ray #'s P-75w/p-75m.
| Device ID | K811230 |
| 510k Number | K811230 |
| Device Name: | X-CELL X-RAY #'S P-75W/P-75M |
| Classification | System, X-ray, Stationary |
| Applicant | X-CEL X-RAY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-04 |
| Decision Date | 1981-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B216MB715NT1 | K811230 | 000 |
| B216715BBD1 | K811230 | 000 |
| B216715RSD1 | K811230 | 000 |
| B216715SD1 | K811230 | 000 |
| B216715TBD1 | K811230 | 000 |
| B216BDXC7001 | K811230 | 000 |
| B216FB715NT1 | K811230 | 000 |
| B216FB910A40K1 | K811230 | 000 |
| B216HDR715A401 | K811230 | 000 |
| B216HDRI715A401 | K811230 | 000 |
| B216LB715NT1 | K811230 | 000 |
| B216P700MAC1 | K811230 | 000 |