Cleared Traditional

K181737 - Raycell MK1 (FDA 510(k) Clearance)

K181737 · Best Theratronics Limited · Radiology device
Jan 2019
Decision
184d
Days
-
Risk

K181737 is an FDA 510(k) clearance for the Raycell MK1. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Best Theratronics Limited (Ottawa, CA). The FDA issued a Cleared decision on January 2, 2019 after a review of 184 days - an extended review cycle.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K181737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2018
Decision Date January 02, 2019
Days to Decision 184 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 128d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class -