The following data is part of a premarket notification filed by Arquilla, Inc. Dba X-cel X-ray Corporation with the FDA for Hf 718bd X-ray System.
| Device ID | K160857 |
| 510k Number | K160857 |
| Device Name: | HF 718BD X-Ray System |
| Classification | System, X-ray, Stationary |
| Applicant | ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION 5220 WALLER ST. STE 1 Crystal Lake, IL 60012 |
| Contact | Guido Arquilla |
| Correspondent | Cynthia J. Pillar CJP Consulting, Inc. 5831 N. Kostner Avenue Chicago, IL 60646 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-29 |
| Decision Date | 2017-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B216HF718BD1 | K160857 | 000 |