The following data is part of a premarket notification filed by Xre Corp. with the FDA for Poly Diagnost Cdx.
| Device ID | K923654 |
| 510k Number | K923654 |
| Device Name: | POLY DIAGNOST CDX |
| Classification | System, X-ray, Angiographic |
| Applicant | XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Contact | Richard A Zablocki |
| Correspondent | Richard A Zablocki XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1992-11-20 |