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FDA 510(k)

MOSAIQ® OIS (Oncology Information System)

K-Number: K223229 · 2023-02-23

ApplicantElekta Solutions AB
Decision Date2023-02-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOSAIQ® OIS (Oncology Information System) is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K223229. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOSAIQ® OIS (Oncology Information System)?

MOSAIQ® OIS (Oncology Information System) is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Elekta Solutions AB. The 510(k) number is K223229.

When did MOSAIQ® OIS (Oncology Information System) receive FDA 510(k) clearance?

MOSAIQ® OIS (Oncology Information System) received FDA 510(k) clearance on 2023-02-23, under 510(k) number K223229.

Who is the listed applicant for MOSAIQ® OIS (Oncology Information System)?

The FDA 510(k) record lists Elekta Solutions AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOSAIQ® OIS (Oncology Information System)?

The FDA product code for MOSAIQ® OIS (Oncology Information System) is IYE.

Other records listing Elekta Solutions AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemK252002Monaco RTP System (6.3)K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)K251363ProKnow DSK250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)K232854Leksell GammaPlan (LGP)

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Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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