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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.
This 510(k) summary does not contain the information required to answer your request. It describes a software module for 3D visualization of ultrasound images but does not include details on acceptance criteria, study design, performance metrics, ground truth establishment, or sample sizes for testing or training. The document primarily focuses on identifying the device, its manufacturer, and predicate devices.
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4/16/99
Page A - 4 510(k) Notification DICOM IMAGE MANAGER - Addition of 3D Visualization Software Module 510 (k) SUMMARY
This following summary is provided as part of this Premarket Notification in compliance with and based on the format set forth in the Final Rule as published in the Federal Register, December 14, 1994. (See 21 CFR § 807.92)
(1) Submitters Name / Contact Person:
Dicomit Imaging Systems Corp. 75 East Beaver Creek Road, Unit 9 Richmond Hill, Ontario Canada L4B 1K6
| Contact Person: | Terry Callahan |
|---|---|
| Tel.: (905) 886-9496 | |
| Fax: (905) 886-2109 | |
| E-mail: tcallahan@dicomit.com |
January 22, 1999 Date prepared:
(2) Name of device:
| Trade Name: | Dicom Image Manager™ "3D ROI™" |
|---|---|
| Common Name: | 3D Visualization Module |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System |
(3) Identification of predicate devices:
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Dicomit Imaging Systems Corp. | Dicom Image Manager | K951925 |
| Advanced Technology Labs | ATL HDI 3000/5000 Ultrasound systems | K961459 |
| General Electric Medical Systems | GE LOGIQ 700 Ultrasound system | K964617 |
(4) Description of the device:
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.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).