# K200889: iMac 27 & PL 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Quantum-Spectra, LLC
- Decided: Jun 2, 2020 after 60 days
- Product code: PGY (Display, Diagnostic Radiology)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K040982 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171229: DELL UP3017 with QUBYX PerfectLum bundle, Qubyx Software Technologies, Inc. (2017) Summary page 4.

## Indications for use
The Apple iMac 27" 5K Retina with PL4.0 is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The device can NOT be used in mammography. The device can NOT be used for a life-support system. The device is intended for prescription use.

Source page: https://510kreport.com/device/K200889
Methodology: https://510kreport.com/methodology