The following data is part of a premarket notification filed by Genesis Software Innovations with the FDA for Preview Shoulder.
| Device ID | K210556 |
| 510k Number | K210556 |
| Device Name: | Preview Shoulder |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Genesis Software Innovations 220 Lyon St NW Suite 500 Grand Rapids, MI 49503 |
| Contact | Matt Miller |
| Correspondent | Matt Miller Genesis Software Innovations 220 Lyon St NW Suite 500 Grand Rapids, MI 49503 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2021-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B973PREVIEWSHOULDER0 | K210556 | 000 |