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The CV70 ultrasound imaging system is intended for the following applications: Abdominal, Fetal, OB/GYN, Cardiac, Intracardiac, Transesophageal, Intraoperative, Small Parts, Transcranial, Cerebrovascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis of information that is used for clinical diagnosis purposes.

The CV70 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect an on-screen display for thermal and re primary or secondary harmonic ultrasound echo data and modiantinin B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, ulsplay it in. D Mode, it would (f Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.

This document is a 510(k) Premarket Notification summary for the ACUSON CV70™ Cardiovascular System, an ultrasound diagnostic system and its associated transducers. It establishes substantial equivalence to previously cleared predicate devices. Therefore, the document describes the device's intended use and technological comparison, rather than presenting a study proving performance against acceptance criteria for a novel AI/CAD device.

As such, the information required for this request (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC study details) is not applicable in this regulatory submission. This document pertains to the market clearance of a diagnostic ultrasound system based on its substantial equivalence to already approved predicate devices, not on a new performance study proving its diagnostic accuracy.

The key points from the provided document are:

• Device Name: ACUSON CV70™ Cardiovascular System
• Device Type: Diagnostic Ultrasound System with Accessories
• Regulation Numbers: 21 CFR 892.1550 (Ultrasonic pulsed doppler imaging system), 21 CFR 892.1560 (Ultrasonic pulsed echo imaging system), 21 CFR 892.1570 (Diagnostic ultrasound transducer), 21 CFR 870.1200 (Diagnostic intravascular catheter)
• Regulatory Class: II
• Product Codes: 90 IYN, IYO, ITX, and 74 DQO
• Predicate Devices: K042770 (ACUSON CV70™ Cardiovascular System) and K042593 (ACUSON Sequoia™ Diagnostic Ultrasound System). This indicates the device is considered substantially equivalent to existing devices, meaning its safety and effectiveness are established by comparison to these predicates rather than requiring a new clinical performance study as might be the case for a novel AI device.
• Intended Uses: Abdominal, Fetal, OB/GYN, Cardiac, Intracardiac, Transesophageal, Intraoperative, Small Parts, Peripheral, Cerebrovascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. It also provides for measurement of anatomical structures and analysis of information for clinical diagnosis.
• Technological Comparison: The CV70 is deemed "substantially equivalent" to the predicate devices. All systems transmit ultrasonic energy, perform post-processing to generate on-screen displays, and allow specialized measurements and calculations.

In summary, this document is a 510(k) clearance, which relies on demonstrating similarity to existing devices, not on a new performance study with acceptance criteria for diagnostic accuracy.

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