CRX WORLD SHUNT

K990256 · Phoenix Biomedical Corp. · JXG · Apr 1, 1999 · Neurology

Device Facts

• Record ID: K990256
• Device Name: CRX WORLD SHUNT
• Applicant: Phoenix Biomedical Corp.
• Product Code: JXG · Neurology
• Decision Date: Apr 1, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Software as a Medical Device

Device Story

Software module for Dicom Image Manager; inputs sequential 2D ultrasound images from standard transducers; transforms images into 3D volume renderings; displays and manipulates 3D images in monitor windows; used in clinical settings by healthcare providers; assists in visualization of anatomical structures; aids clinical assessment of ultrasound data.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Software-based 3D visualization module; operates on Dicom Image Manager platform; processes sequential 2D ultrasound images; enables 3D rendering and manipulation; standalone software module.

Indications for Use

Indicated for use by clinicians to store sequential ultrasound images and render them into 3D images for display and manipulation during standard ultrasound scanning procedures.

Regulatory Classification

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.

Predicate Devices

• Dicom Image Manager (K951925)
• ATL HDI 3000/5000 Ultrasound systems (K961459)
• GE LOGIQ 700 Ultrasound system (K964617)

Submission Summary (Full Text)

{0}------------------------------------------------

4/16/99

## Page A - 4 510(k) Notification DICOM IMAGE MANAGER - Addition of 3D Visualization Software Module 510 (k) SUMMARY

K990248

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.: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |

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.