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FDA 510(k)

AI-Rad Companion (Pulmonary)

K-Number: K233753 · 2024-03-21

ApplicantSiemens Healthcare GmbH
Decision Date2024-03-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion (Pulmonary) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K233753. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-Rad Companion (Pulmonary)?

AI-Rad Companion (Pulmonary) is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K233753.

When did AI-Rad Companion (Pulmonary) receive FDA 510(k) clearance?

AI-Rad Companion (Pulmonary) received FDA 510(k) clearance on 2024-03-21, under 510(k) number K233753.

Who is the listed applicant for AI-Rad Companion (Pulmonary)?

The FDA 510(k) record lists Siemens Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI-Rad Companion (Pulmonary)?

The FDA product code for AI-Rad Companion (Pulmonary) is JAK.

Other records listing Siemens Healthcare GmbH 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.

K253264myAblation Guide (VC10A)K253689syngo Dynamics (VA41F)K252548AI-Rad Companion Organs RTK253057AI-Rad Companion Brain MRK252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseK252608AI-Rad Companion Prostate MR

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Related Devices (Code: JAK)

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

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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