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Vancouver, BC –TheNewswire –September6, 2023–
The lzoView CT Imaging System is intended to produce cross-sectional images of anatomy that can be imaged in the 30 cm aperture by computer reconstruction of x-ray transmission data for noninvasive visualization of tissue.
The lzoView CT Imaging System is indicated for use in the non-invasive visualization of breast tissue, as an adjunct tool to mammography, by providing x-ray computer reconstructed images as an aid for qualified healthcare providers.
Upon an anticipated acceptance of the pre-submission application from the FDA, the Company intends to complete the 510(k)-submission using pre-existing data from phantom images obtained from the IzoView system located in its engineering facility in
The Company also intends to secure collaborations with notable hospitals to utilize IzoView as an investigational device. Such partnerships are expected to generate clinical data that would support new IzoView products and Indications for Use for new regulatory submissions in the future. See the attached (below)Figure 1: Go To Market Plan.
Explanation of Changes: Class III Pre-Market Approval to Class II 510(k)
In June of 2023,
Under the Class III pathway,
Supporting Class II 510(k) Pathway
According to the FDA, a “510(k) requires demonstration of substantial equivalence to another legally
Given theseparameters,
The following predicate table,Figure 2:Izotropic Class II Device Submission Predicates, showcases select information, including Intended Use and Indication for Use statements for all three devices. IzoView is comparable, with each system having specific anatomical indications.
Device | Izotropic IzoView | CurveBeam HiRise | NeuroLogica OmniTom |
Photo | |||
Intended Use & Indication for Use | The IzoView CT Imaging System is intended to produce cross-sectional images ofanatomythat can be imaged in the 30 cm aperture by computer reconstruction of x-ray transmission data for non-invasive visualization of tissue. IzoView is indicated for use in the non-invasive visualization ofbreast tissue, as adjunct to mammography, as an aid for qualified healthcare professionals. | The HiRise is intended to be used for 3-D imaging of theupper and lower extremities and pelvisof adult and pediatric patients weighing from 40 to 450 lbs. The device is to be operated in a professional healthcare environment by qualified health care professionals only. | The NL5000 [OmniTom] system is intended to be used for xray computed tomography applications foranatomythat can be imaged in the 40 cm aperture,primarily head and neck. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast. |
510(k) No. | In Progress | K203187 | K171183 |
Product Code | Proposed: JAK (System, X-Ray, Tomography, Computed) | JAK (System, X-Ray, Tomography, Computed) | JAK (System, X-Ray, Tomography, Computed) |
Principle of Operation | Cone beam computed tomography x-ray imaging | Cone beam computed tomography x-ray | Computed tomography 3D x-ray imaging |
Additional Information | -Seeking FDA Clearance -Comparable gantry, scan axis, aperture bore, radiation shielding (improved for both technologist and general public), and x-ray tubes and additional technical aspects as HiRise and OmniTom - 51,955,021 shares issued | -FDA Clearance in 2020 -Based in -IPO -182,863,995 shares issued -Website link here | -16 Slice CT Scanner -FDA Clearance in 2017 -Acquired by Samsung in 2013 for undisclosed terms -Website link here |
Figure 2: Class II Device Submission Predicates.
Given the similarities to the CurveBeam HiRise and NeuroLogica OmniTom devices that are already cleared for sale in the
ON BEHALF OF THE BOARD
Mr.
Cell: 604-220-5031
Contact:
Email:info@izocorp.com
Toll Free: 1-833-IZOCORP ext.1
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Forward-Looking Statements
This document may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions, projections, and expectations of the Company's management, business, and its knowledge of the relevant market and economic environment in which it operates. The Company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words.
These statements are not guarantees of performance and involve risks, including those related to capital requirements and uncertainties that are difficult to control or predict, and as such, they may cause future results of the Company's activity to differ significantly from the content and implications of such statements. Forward-Looking Statements are pertinent only as of the date on which they are made, and the Company undertakes no obligation to update or revise any Forward-Looking Statements to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law. Neither the Company nor its shareholders, officers, and consultants shall be liable for any action and the results of any action taken by any person based on the information contained herein, including, without limitation, the purchase or sale of Company securities. Nothing in this document should be deemed to be medical or other advice of any kind. All images are for illustrative purposes only. IzoView is not yet approved for sale.
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[1]https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
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