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510(k) K200889

iMac 27 & PL 4.0 by Quantum-Spectra, LLC — Product Code PGY

K200889 is an FDA 510(k) premarket notification submitted by Quantum-Spectra, LLC for the device "iMac 27 & PL 4.0". The FDA issued a decision of Substantially Equivalent on Jun 2, 2020. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 2, 2020
Date Received
Apr 3, 2020
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.

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FDA data resources