Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

syngo.via MI Workflows; Scenium; syngo MBF

K-Number: K242275 · 2024-08-30

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2024-08-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.via MI Workflows; Scenium; syngo MBF is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2024-08-30 under approval number K242275. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the syngo.via MI Workflows; Scenium; syngo MBF?

syngo.via MI Workflows; Scenium; syngo MBF is a medical device that received FDA 510(k) clearance on 2024-08-30. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K242275.

When was syngo.via MI Workflows; Scenium; syngo MBF approved by the FDA?

syngo.via MI Workflows; Scenium; syngo MBF received FDA 510(k) clearance on 2024-08-30, under approval number K242275.

What company makes syngo.via MI Workflows; Scenium; syngo MBF?

syngo.via MI Workflows; Scenium; syngo MBF is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo.via MI Workflows; Scenium; syngo MBF?

The FDA product code for syngo.via MI Workflows; Scenium; syngo MBF is QIH.

Other Devices by Siemens Medical Solutions USA, Inc.

K162302Somatom Confidence ® RT Pro K162971Multix Fusion Max K161795MAGNETOM ESSENZA K162541syngo Application Software K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT K162370syngo.via RT Image Suite

View all 248 devices →

Related Devices (Code: QIH)

K191647QLAB Advanced Quantification SoftwarePhilips Health Care K191171EchoGo CoreUltromics, Ltd. K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. K202546LVivo SeamlessDia Imaging Analysis, Ltd. K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, 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.

↑