Search Results

ARMI® Hysteroscopy System 2.0 is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

The ARMI® Hysteroscopy System 2.0 (subject device) is a hysteroscope and compatible accessories consisting of the following components:

• ARMI® Endoscopic Video Image Processor (non-sterile, reusable), JY-MIP-3000
• ARMI® Single-Use Hysteroscope (sterilized with ethylene oxide), SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C
• Disposable Electronic Hysteroscope (sterilized with ethylene oxide) (510(k) cleared under K210270),
• Power cord and Power adapter (non-sterile, reusable),
• Hysteroscope cable (non-sterile, reusable), and
• HDMI cable (non-sterile, reusable) (optional)

Both hysteroscopes are single-use and the rest of the components are reusable.

The image processor is powered by an AC adapter (100 – 240V AC, 50/60 Hz) or battery (7.4V DC).

The subject device includes 13 models of the ARMI Single-Use Hysteroscope. The models have a working length of 245 mm. The models have different image resolutions, tip angles, insertion diameters, and instrument channel diameters.

The subject devices are noted to contain two different LED models (0301, 9653) and three different image sensors (ovm6946/ochsa10/ov9734).

N/A

Ask a specific question about this device