The following data is part of a premarket notification filed by Realcloud Imaging Inc. Dba Realcloud Imaging with the FDA for Brasseler Gem, Brasseler Gem10, Brasseler Gem15, Brasseler Gem20.
| Device ID | K221955 |
| 510k Number | K221955 |
| Device Name: | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | RealCloud Imaging Inc. Dba RealCloud Imaging 2625 North Loop Drive, Suite 2130 Ames, IA 50010 |
| Contact | Douglas A Golay |
| Correspondent | Ed Johansen W. Edward Johansen 1239 Stanford Street, Apartment Number 205 Santa Monica, CA 90404 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040165270 | K221955 | 000 |
| 00887919950073 | K221955 | 000 |