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Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Pediatric, small organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, musculo-skeletal (conventional), musculo- skeletal (superficial), thoracic/pleural, Cardiac Adult, Cardiac Pediatric and Peripheral vessel exams.

It is intended to provide 50Hz shear wave speed measurements (ViTE: Visual Transient Elastography) and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (LiSA: Liver Ultra-Sound Attenuation) in internal structures of the body.

It is also intended to measure spleen stiffness using ViTE at 100 Hz shear wave frequency.

The liver stiffness measurement by ViTE may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis.

The coefficient of attenuation measurement by LiSA may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.

ViTE and LiSA is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of patients with liver disease, as part of an overall assessment of liver.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PW Doppler, CWD, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging (Contrast agent for Liver), ViTE, LiSA and Combined mode: B+M, PW+M, Color+B, Power+B, PW+Color+B, Power+PW+B, iScape View, TDI.

The Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PW Doppler, CWD, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Biopsy guidance, Color M, Contrast imaging (Contrast agent for Liver), ViTE, LiSA and Combined mode: B+M, PW+M, Color+B, Power+B, PW+Color+B, Power+PW+B, iScape View, TDI.

The Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

Compared to the predicate device Hepatus 7 (K200643), the new features of the subject device are listed in the table below.

Items: Indications for uses, New features: small organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), thoracic/pleural, Cardiac Adult, Cardiac Pediatric.
Items: Indications for uses, New features: Spleen stiffness measurement using ViTE at 100 Hz.

The liver stiffness measurement by ViTE may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis.

The coefficient of attenuation measurement by LiSA may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.

ViTE and LiSA is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of patients with liver disease, as part of an overall assessment of liver.

Probes: LFC5-1s, L9-3s, L15-3RCs, P4-2s
Needle-guided brackets: NGB-034, NGB-011, NGB-043
Functions: iScape View, CW, Tissue Doppler Imaging, Spleen ViTE, Small Parts Package, Pediatrics Package, Nerve Package, Cardiology Package, Emergency&Critical Package

N/A

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The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8/Nuda/Aquila/Malody Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic,adult cephalic,trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , Laparoscopic, trans-esoph(Cardiac) exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

The MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided FDA 510(k) Clearance Letter states that clinical studies were Not Applicable for the Mindray Diagnostic Ultrasound System (K251192) to support substantial equivalence. Therefore, there is no information in this document about acceptance criteria or a study proving the device meets specific performance criteria through clinical data.

The letter explicitly states:
"8. Clinical Studies
Not applicable. The subject of this submission, MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Instead, the submission relies on:

• Comparison with Predicate Devices: The document extensively details how the subject device is comparable and substantially equivalent to existing cleared predicate devices (e.g., MX7 (K241432), TEX20 (K241201), Resona I8W (K240115), TE Air (K240906), Consona N6 (K221300), QLAB (K190913)) in terms of intended use, imaging modes, features, functions, and technological characteristics.
• Non-clinical Tests: The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, in compliance with various recognized standards (e.g., NEMA UD 2-2004, ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-1).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device performance as they would apply to clinical efficacy/performance for a new AI/software component, because this information is not present in the provided 510(k) summary. The clearance is based on substantial equivalence to existing predicate ultrasound systems and non-clinical safety/performance testing.

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