510(k) K160328
K160328 is an FDA 510(k) premarket notification submitted by The Linden Group Corp for the device "DIVA ZSP2105CMI with QUBYX PerfectLum bundle". The FDA issued a decision of Substantially Equivalent on Feb 25, 2016. 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
- Feb 25, 2016
- Date Received
- Feb 5, 2016
- 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.