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RayStation 6

by RaySearch Laboratories AB (PUBL)

510(k) K170355

RayStation 6 is a Class II device made by RaySearch Laboratories AB (PUBL), cleared under FDA 510(k) K170355 on 2 Mar 2017, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170355 Date2 Mar 2017ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1193-2025 FDA Class II initiated 16 Jan 2025

    Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

Timeline

2 dated events

  1. Cleared FDA 510(k) K170355
  2. Recall initiated FDA recalls Z-1193-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MUJ
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K170355

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K170355
UDI-DISize and differences
RayStation 6.0
RaySearch Laboratories AB (PUBL)
6.007350002010013 —On the market

Similar devices

Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).

Other devices from RaySearch Laboratories AB (PUBL)

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