(80 days)
The DICOMIT Dicom Image Manager medical image management system is intended for acceptance, transfer, display, storage and digital processing of medical images. The software component provides functions for performing operations related to image manipulation.
The "3D ROI" software option enables the device to display and manipulate an adjunctive 3D volume image created with data from a diagnostic ultrasound scanning procedure.
The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.
The provided text describes a 510(k) premarket notification for the DICOMIT Dicom Image Manager - Addition of 3D Visualization Software Module. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
The document focuses on:
- Identifying the submitter and device.
- Classifying the device and its intended use.
- Comparing it to predicate devices to establish substantial equivalence.
- The FDA's decision to clear the device based on substantial equivalence.
Therefore, I cannot provide the requested table and details because the information is not present in the given text. The FDA clearance is based on substantial equivalence to existing devices, implying that detailed performance studies might not have been required for this specific 510(k) submission, as the fundamental technology and intended use were deemed similar to devices already on the market.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.