The following data is part of a premarket notification filed by Ray Co., Ltd with the FDA for Rayscan A-expert.
Device ID | K122918 |
510k Number | K122918 |
Device Name: | RAYSCAN A-EXPERT |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | RAY CO., LTD 8920 WILSHIRE BLLVD SUITE 603 Beverly Hills, CA 90211 |
Contact | Andrew Paeng |
Correspondent | Andrew Paeng RAY CO., LTD 8920 WILSHIRE BLLVD SUITE 603 Beverly Hills, CA 90211 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-24 |
Decision Date | 2013-03-15 |
Summary: | summary |