The following data is part of a premarket notification filed by Mint Labs, Inc., D/b/a. Qmenta with the FDA for Qmenta Care Platform Family.
| Device ID | K202718 |
| 510k Number | K202718 |
| Device Name: | Qmenta Care Platform Family |
| Classification | System, Image Processing, Radiological |
| Applicant | Mint Labs, Inc., D/b/a. QMENTA One International Place, Suite 3700 Boston, MA 02110 |
| Contact | Paulo Rodrigues |
| Correspondent | Paulo Rodrigues QMENTA Imaging S.L. C/ Roger De Lluria 46, Pral. 1 08009 Barcelona, ES 08009 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-17 |
| Decision Date | 2021-06-16 |