510(k) · Radiology

RayStation 11B

by RaySearch Laboratories AB (publ)

RayStation 11B is an AI-enabled medical device from RaySearch Laboratories AB (publ) that the U.S. FDA cleared through 510(k) K220141 on April 15, 2022. Its lead review panel is Radiology and its primary product code is MUJ (System, Planning, Radiation Therapy Treatment).

See also FDA-cleared AI radiology devices in 2022, all FDA AI clearances in 2022, top radiology AI devices.

Key facts

Submission numberK220141
Pathway510(k)
Date of final decision
Company (FDA list)RaySearch Laboratories AB (publ)
Lead review panelRadiology
Primary product codeMUJ — System, Planning, Radiation Therapy Treatment
Applicant (openFDA)RaySearch Laboratories AB (PUBL)
Applicant locationStockholm, SE
Device classClass 2
Regulation number21 CFR 892.5050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. RayStation 11B went through this pathway (K220141).

openFDA lists it as a Class 2 device under 21 CFR 892.5050. Class II devices are moderate risk and are subject to general and special controls.

Product code MUJ covers 33 devices on the FDA AI list. By decision date, this device is #15 of 33 under that code. RaySearch Laboratories AB (publ) has 8 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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