Cleared Traditional

K193317 - CoreLite X-Ray Specimen Cabinet

K193317 is the FDA 510(k) clearance for CoreLite X-Ray Specimen Cabinet by Cirdan Imaging Limited. It is a Class 2 Radiology device (product code MWP) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K193317 · Cirdan Imaging Limited · Radiology device
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Dec 2019
Decision
14d
Days
Class 2
Risk

K193317 is an FDA 510(k) clearance for the CoreLite X-Ray Specimen Cabinet. Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Cirdan Imaging Limited (Lisburn, GB). The FDA issued a Cleared decision on December 13, 2019 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Cirdan Imaging Limited devices

Submission Details

510(k) Number K193317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2019
Decision Date December 13, 2019
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MWP Cabinet, X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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

Regulatory Technology Services, LLC
Prithul Bom

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 - MWP Cabinet, X-ray System

All 15
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