Cleared Traditional

K212587 - 3D-RD-S (FDA 510(k) Clearance)

Class I Radiology device.

K212587 · Radiopharmaceutical Imaging and Dosimetry, LLC · Radiology device
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Feb 2023
Decision
555d
Days
Class 1
Risk

K212587 is an FDA 510(k) clearance for the 3D-RD-S. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Radiopharmaceutical Imaging and Dosimetry, LLC (Baltimore, US). The FDA issued a Cleared decision on February 22, 2023 after a review of 555 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Radiopharmaceutical Imaging and Dosimetry, LLC devices

Submission Details

510(k) Number K212587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2021
Decision Date February 22, 2023
Days to Decision 555 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
448d slower than avg
Panel avg: 107d · This submission: 555d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.