The following data is part of a premarket notification filed by Konica Minolta Healthcare Americas, Inc. with the FDA for Exa.
| Device ID | K203743 |
| 510k Number | K203743 |
| Device Name: | EXA |
| Classification | System, Image Processing, Radiological |
| Applicant | Konica Minolta Healthcare Americas, Inc. 2217 Us Highway 70 E Garner Garner, NC 27529 |
| Contact | Carolyn Russell |
| Correspondent | Scott Blood MEDicept, Inc 200 Homer Ave Ashland, MA 01721 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-22 |
| Decision Date | 2021-12-10 |