The following data is part of a premarket notification filed by Dynarad Corp. with the FDA for Facts Monoblock.
| Device ID | K981267 |
| 510k Number | K981267 |
| Device Name: | FACTS MONOBLOCK |
| Classification | Collimator, Manual, Radiographic |
| 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 | IZX |
| Subsequent Product Code | ITY |
| Subsequent Product Code | IZO |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-07 |
| Decision Date | 1998-05-06 |