DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K102865
Substantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.
FDA 510(k) clearance K102865 for DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2010-11-03. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Great Neck, NY, US
Recent devices under product code ITX
view allMore clearances from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
view all- 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)
- K260846 — Diagnostic Ultrasound System (13+ models)
- K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
- K252182 — SV70 Ventilator (SV70)
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . 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.