The following data is part of a premarket notification filed by Dynarad Corp. with the FDA for X-ray Monoblock, Monoblock Xrs-60-330.
| Device ID | K000052 |
| 510k Number | K000052 |
| Device Name: | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729 |
| Contact | Raymonf Manez |
| Correspondent | Raymonf Manez DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729 |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-07 |
| Decision Date | 2000-02-10 |