MD-6000S Bladder Scanner— 510(k) K260313

Name: FDA 510(k) clearance K260313
Creator: U.S. Food and Drug Administration
Published: 2026-09-24

Substantially Equivalent

MEDA Co., Ltd.

FDA 510(k) clearance K260313 for MD-6000S Bladder Scanner, Substantially Equivalent on 2026-09-24. Applicant: MEDA Co., Ltd.. Device class: 2.

Summary

The MD-6000S Bladder Scanner is filed under IYO, pulsed echo ultrasonic imaging systems. The record doesn't give this unit's specs or say what it measures beyond the name and code.

Class II, 21 CFR 892.1560. The Radiology panel reviewed it as a Traditional 510(k).

MEDA Co., Ltd. filed from Tianjin, China. Review took 237 days (January 30 to September 24, 2026).

Clearance details

Applicant: MEDA Co., Ltd.
Product code: Product code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2026-01-30
Decision date: 2026-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

view all

K253452 — Accuro 3S2026-07-24
K260190 — ARTHUR2026-06-18
K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

More clearances from MEDA Co., Ltd.

view all

K213070 — MD-320W Ultrasound Biomicroscope2021-11-18
K182460 — MD-6000P Bladder Scanner2019-05-06
K152318 — MD-2300S Ultrasonic A/B Scanner for Ophthalmology2015-11-17
K121243 — ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER2013-05-03
K113304 — BLADDER SCANNER2012-03-23

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.