Cleared Traditional

K200889 - iMac 27 & PL 4.0

K200889 is the FDA 510(k) clearance for iMac 27 & PL 4.0 by Quantum-Spectra, LLC. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K200889 · Quantum-Spectra, LLC · Radiology device
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Jun 2020
Decision
60d
Days
Class 2
Risk

K200889 is an FDA 510(k) clearance for the iMac 27 & PL 4.0. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Quantum-Spectra, LLC (Wilmington, US). The FDA issued a Cleared decision on June 2, 2020 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quantum-Spectra, LLC devices

Submission Details

510(k) Number K200889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2020
Decision Date June 02, 2020
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Quantum Spectra, LLC
Marc Leppla

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PGY Display, Diagnostic Radiology

All 82
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