The following data is part of a premarket notification filed by Inspirata, Inc. with the FDA for Dynamyx Digital Pathology Software.
| Device ID | K210811 |
| 510k Number | K210811 |
| Device Name: | Dynamyx Digital Pathology Software |
| Classification | Digital Pathology Image Viewing And Management Software |
| Applicant | Inspirata, Inc. One North Dale Mabry Hwy Suite 600 Tampa, FL 33609 |
| Contact | Richard Morroney |
| Correspondent | Richard Morroney Inspirata, Inc. One North Dale Mabry Hwy Suite 600 Tampa, FL 33609 |
| Product Code | QKQ |
| CFR Regulation Number | 864.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-17 |
| Decision Date | 2022-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854904006039 | K210811 | 000 |