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 |