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)

Bladder Scanner (Models: M2, M2-W, M1, M1-W)

K-Number: K190769 · 2019-05-22

ApplicantSuzhou Lischka Medtech Co., Ltd.
Decision Date2019-05-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder Scanner (Models: M2, M2-W, M1, M1-W) is a medical device manufactured by Suzhou Lischka Medtech Co., Ltd.. It received FDA 510(k) clearance on 2019-05-22 under approval number K190769. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bladder Scanner (Models: M2, M2-W, M1, M1-W)?

Bladder Scanner (Models: M2, M2-W, M1, M1-W) is a medical device that received FDA 510(k) clearance on 2019-05-22. It is manufactured by Suzhou Lischka Medtech Co., Ltd.. The 510(k) number is K190769.

When was Bladder Scanner (Models: M2, M2-W, M1, M1-W) approved by the FDA?

Bladder Scanner (Models: M2, M2-W, M1, M1-W) received FDA 510(k) clearance on 2019-05-22, under approval number K190769.

What company makes Bladder Scanner (Models: M2, M2-W, M1, M1-W)?

Bladder Scanner (Models: M2, M2-W, M1, M1-W) is manufactured by Suzhou Lischka Medtech Co., Ltd..

What is the FDA product code for Bladder Scanner (Models: M2, M2-W, M1, M1-W)?

The FDA product code for Bladder Scanner (Models: M2, M2-W, M1, M1-W) is IYO.

Related Clinical Trials

NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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.

↑