The following data is part of a premarket notification filed by Takara Belmont Corp. with the FDA for Alphard Cone Beam Ct, Model X178.
| Device ID | K072574 |
| 510k Number | K072574 |
| Device Name: | ALPHARD CONE BEAM CT, MODEL X178 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TAKARA BELMONT CORP. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm TAKARA BELMONT CORP. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-13 |
| Decision Date | 2007-10-18 |
| Summary: | summary |