Cleared Traditional

K210645 - RayStation 10.1

K210645 is an FDA 510(k) clearance for RayStation 10.1, manufactured by RaySearch Laboratories AB (PUBL). The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K210645 · RaySearch Laboratories AB (PUBL) · Radiology device
Download Printable Device Report (PDF)
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Jun 2021
Decision
118d
Days
Class 2
Risk

K210645 is an FDA 510(k) clearance for the RayStation 10.1. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by RaySearch Laboratories AB (PUBL) (Stockholm, SE). The FDA issued a Cleared decision on June 29, 2021 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: 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.

View all RaySearch Laboratories AB (PUBL) devices

FDA 510(k) Submission Details - K210645

510(k) Number K210645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2021
Decision Date June 29, 2021
Days to Decision 118 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
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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.

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All 144
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