FDA cleared the Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. on May 11, 2026 under K260846, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.
FDA logged the submission as received on Mar 16, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K253330 (A5 Anesthesia System (A5); A7 Anesthesia System (A7)), K260098 (ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)), K253170 (uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors), K252182 (SV70 Ventilator (SV70)).
Questions & Answers
What did FDA clear under K260846?
K260846 is the FDA 510(k) for Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos, submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. FDA's decision date was May 11, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).
Who makes the Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos?
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., based in Shenzhen, is the applicant of record for K260846.
How long did the K260846 review take?
FDA received the submission on Mar 16, 2026 and issued its decision on May 11, 2026, 56 days later.