No, the DViS is considered a Class 2 device (medium-risk). Many people blatantly throw the "PMA-route" reference out there when it comes to the Dominion's FDA 510k progress, but this is just misleading, false, and unnecessary. According to the text below, the DViS would definitely be classified as a Class 2 device which would only require a 510k marketing clearance with the FDA...
Device Classification
There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device. As the classification level increases, the risk to the patient and FDA regulatory control increases. Accessories to medical devices, devices used with a medical device to support use of the device, are considered the same classification as the medical device.
The FDA classification of medical devices is based upon classifications for devices currently legally marketed in the United States. The FDA determines the device classification by the device intended use and risk the device presents to the patient. New medical devices are compared to legally marketed medical device classifications with the same intended use and technological characteristics to determine the device classification.
Class I medical devices have the least amount of regulatory control. Class I devices present minimal potential harm to the user. Class I devices are typically simple in design, manufacture and have a history of safe use. Examples of Class I devices include tongue depressors, arm slings, and hand-held surgical instruments. Most Class I devices are exempt from the premarket notification and may be exempt from compliance with the good manufacturing practices regulation.
Class II medical devices are devices where General Controls are not sufficient to assure safety and effectiveness and existing methods/standards/guidance documents are available to provide assurances of safety and effectiveness. In addition to compliance with General Controls, Class II devices are required to comply with Special Controls. Special Controls include:
Special labeling requirements,
Mandatory performance standards, both International and United States
Postmarket surveillance
FDA medical device specific guidance
Class II devices typically require pre-market notification by submission and FDA review of a 510(k) clearance to market submission. A few Class II devices are exempt from the premarket notification. Information on Class II exempt devices is located within the device regulation, 21 CFR 862 through 892. Examples of Class II devices include physiologic monitors, x-ray systems, gas analyzers, pumps, and surgical drapes.
Class III medical devices have the most stringent regulatory controls. For Class III medical devices, sufficient information is not available to assure safety and effectiveness through the application of General Controls and Special Controls. Class III devices usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient. Typically a Pre-Market Approval (PMA) submission to the FDA is required to allow marketing of a Class III medical device. A few Class III medical devices are required to only have a 510(k) cleared by the FDA to be marketed. Examples of Class III devices that require a PMA are: replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.
Also, there are no set deadlines with the FDA and 510k submission. Unfortunately this has taken a while, but we are still on track for approval I think fairly soon. I've justified the duration of time this has taken throughout this process by examining the following from the FDA's website...
510(k) Clearance to Market
The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.
The information required in a 510(k) submission is defined 21 CFR 807.87. A 510(k) submission includes:
Device trade or proprietary name, common or usual name or classification, Class of the device (Class I, II, III)
Submitter's name and address, Contact person, telephone number and fax number, Representative/Consultant if applicable
Name and address of manufacturing/packaging/sterilization facilities, Registration number of each manufacturing facility
Action taken to comply with the requirements of the Special Controls.
Proposed labels, labeling, and advertisements to describe the device, its intended use, and the directions for its use.
510(k) summary or a 510(k) statement.
For Class III medical device, a Class III certification and a Class III summary.
Photographs of the device, Engineering drawings of the device.
Identification of the marketed device(s) to which equivalence is claimed including labeling and description of the medical device.
Statement of similarities and/or differences with marketed device(s)
Data to show consequences and effects of a modified device, performance Data (bench, animal, clinical)
Sterilization information (as applicable)
Software development, verification and validation information
Hardware design and development information
Information requested in specific guidance documents (as applicable)
Kit Certification Statement (for a 510(k) submission with kit components only)
Truthful and Accurate Statement
Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process.
I strongly believe that Imaging3 has made such a revolutionary product in the Dominion that they had to make many changes in order for this machine to be actually pretty unique compared to others, yet still derive from its predicate devices as far as equivalency is concerned. I think the FDA finally understands that this machine indeed is just a useful upgrade of the technology that currently exists and is approved by them.
The Dominion's predicate devices are the 9990 Plus Mobile Fluoroscopy System, and the LightSpeed 7.1 CT Scanner System (with many of the same/similar hardware components, but major changes in the software aspect).
Hopefully approval will come soon as we have all waited forever as it seems. However, among us all, Dean Janes has waited the longest and he will profit the most from this all. I certainly think he won't give up until this thing has passed the FDA's ultimate test.
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