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)

Saige-Density

K-Number: K222275 · 2022-12-16

ApplicantDeepHealth, Inc.
Decision Date2022-12-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Saige-Density is a medical device manufactured by DeepHealth, Inc.. It received FDA 510(k) clearance on 2022-12-16 under approval number K222275. 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 Saige-Density?

Saige-Density is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by DeepHealth, Inc.. The 510(k) number is K222275.

When was Saige-Density approved by the FDA?

Saige-Density received FDA 510(k) clearance on 2022-12-16, under approval number K222275.

What company makes Saige-Density?

Saige-Density is manufactured by DeepHealth, Inc..

What is the FDA product code for Saige-Density?

The FDA product code for Saige-Density is QIH.

Other Devices by DeepHealth, Inc.

K203517Saige-Q K220105Saige-Dx K243705Saige-Density (2.5.0) K243688Saige-Dx (3.1.0) K241747Saige-Dx K251873Saige-Dx

View all 8 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.

↑