The following data is part of a premarket notification filed by Takara Belmont Usa, Inc. with the FDA for Adr Plus Ssxi Imaging Device For X-ray Systems Such As X-caliber, X-caliber Cm, Ana-bel And Ana-bel Cm.
| Device ID | K041834 |
| 510k Number | K041834 |
| Device Name: | ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Product Code | MUH |
| Subsequent Product Code | EHD |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-07 |
| Decision Date | 2004-12-03 |