510(k) K191705
K191705 is an FDA 510(k) premarket notification submitted by The Linden Group Corp for the device "OptikView GUP2103CMI". The FDA issued a decision of Substantially Equivalent on Mar 16, 2020. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050. The Linden Group Corp has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 2020
- Date Received
- Jun 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Diagnostic Radiology
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.