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Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Multi View (MView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer.

The provided document is a 510(k) summary for the Esaote 7340 Ultrasound System, submitted to the FDA in 2008. It primarily details the device's intended use and compares its technological characteristics to predicate devices for demonstrating substantial equivalence.

Crucially, this document does NOT contain information about specific acceptance criteria, studies proving device performance against those criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or the type of ground truth used.

The tables within the document (pages 8-10, 15-16) list the clinical applications and modes of operation available on the 7340 system and its predicate devices, as well as for various transducers. The 'N' and 'P' in these tables indicate whether a particular clinical application and mode is 'New' (first introduced with this device for that application) or 'Previously cleared' (using transducers approved in prior submissions) for the specific transducer being discussed. This is a comparison for substantial equivalence, not a performance study against acceptance criteria.

Therefore, I cannot provide the requested information from this document. The sections you asked for are typically found in detailed performance studies, clinical trials, or validation reports, which are not included in this 510(k) summary.

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