The following data is part of a premarket notification filed by Takara Belmont Usa, Inc. with the FDA for Phot-x Ii, Model 303.
| Device ID | K042260 |
| 510k Number | K042260 |
| Device Name: | PHOT-X II, MODEL 303 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | TAKARA BELMONT USA, INC. 101 BELMONT DR. Somerset, NJ 08873 |
| Contact | Masahiro Kanaya |
| Correspondent | Elizabeth Drew UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-23 |
| Decision Date | 2004-09-07 |
| Summary: | summary |