The following data is part of a premarket notification filed by Dynarad Corp. with the FDA for Nova Xm2.
| Device ID | K932356 |
| 510k Number | K932356 |
| Device Name: | NOVA XM2 |
| Classification | System, X-ray, Mammographic |
| Applicant | DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729 |
| Contact | Raymond Manez |
| Correspondent | Raymond Manez DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-13 |
| Decision Date | 1995-02-08 |