Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Also cleared against K221300: 1 other device →

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

• K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 10 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
• K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 10 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
• K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
• K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
• K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
• K960330InstatrakVisualization Technology, Inc. · 1996 · 10 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

• The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 8 months on median.
• 90 of the 360 ancestors have a recall of any class; 6 have a Class I recall.
• 1 other device also cites its predicate K221300.

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

What is it indicated for?

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.