Vivos Inc (RDGL)

[DiamondFire]

Tim222: I found it! Look at these FDA Class II description for devices, therapies, procedures etc(!!!): sorry a little excited as your post forced me to do more DD, lol

First of all: thank you Tim222! What i found just blew my mind on the FDA site.

-- Guys, not only does the Class II classification that ADMD's device is going after fit perfectly in with so many Class II FDA ones below (and some very similar ones !) -- looking below at these examples -- well a Class II classification seems a very good possibility and makes the most sense.

lol it aint just wheel chairs in FDA Class II brah! Check it out Tim222:

...first of all this is what ADMD. Is trying to get reclassified:

Yttrium 90 RadioGel™ and Polymer Seeds.
The future of radioactive brachytherapy.

Advanced Medical Isotope Corporation has obtained an exclusive license to eight (8) patents for injectable RadioGel™ technology for use in high-dose radiation therapy. The license was granted by *Battelle pursuant to an option between Battelle and AMIC announced in February 2011.

The Agreement grants AMIC an exclusive license to make, have made, use and sell a RadioGel™ system including an injectable, water-based biodegradable polymer that delivers Yttrium-90 microspheres directly into tumor tissues. The solution warms to body temperature quickly after injection and then polymerizes into a lattice that traps the Yttrium-90 microspheres in place. High-energy beta particles from Yttrium-90 efficiently irradiate cancer cells within the targeted volume but very little radiation escapes. This feature maximizes the overall radiation dose to cancer cells while minimizing radiation exposure and associated side-effects in nearby normal tissues.


KENNEWICK, Wash., Dec. 23, 2014 /PRNewswire/ -- Advanced Medical Isotope Corporation ("AMIC") (OTCQB: ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that it has filed a de novo submission with the Food and Drug Administration ("FDA") for marketing clearance for its patented Y-90 RadioGel™ device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act (the "Act").

By filing the de novo submission, the Company is seeking reclassification of the product to Class II.

http://isotopeworld.investorroom.com/2014-12-23-Advanced-Medical-Isotope-Corporation-Files-a-de-novo-Submission-for-Y-90-RadioGel-Device


Now guys read below(!)....these are alllllllll Class II !! There are many more in many medical fields @ Class II ...but i found these to be very similar to ADMD's device and therapy...as they are into radiation therapies and delivery devices too:

And dudes...lol...this first one listed below....well is that as close of a medical match as one could find for ADMD?? Even better ::: ADMD uses a BIODEGRADABLE capsule unlike the below listed gold, titanium, steel or platinum that STAYS in the body:: Wooooooooooooooo!::

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PART 892 -- RADIOLOGY DEVICES

Subpart F--Therapeutic Devices

Sec. 892.5730 Radionuclide brachytherapy source.
(a) Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

(b) Classification. Class II.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5730

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PART 892 -- RADIOLOGY DEVICES

Subpart F--Therapeutic Devices

Sec. 892.5050 Medical charged-particle radiation therapy system.
(a) Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 64 FR 1125, Jan. 8, 1999]

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5050


PART 892 -- RADIOLOGY DEVICES

Subpart F--Therapeutic Devices

Sec. 892.5300 Medical neutron radiation therapy system.
(a) Identification. A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment support, treatment planning computer programs, component parts, and accessories.

(b) Classification. Class II.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5300


SUBCHAPTER H--MEDICAL DEVICES
PART 892 -- RADIOLOGY DEVICES

Subpart F--Therapeutic Devices

Sec. 892.5750 Radionuclide radiation therapy system.
(a) Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

(b) Classification. Class II.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5750



...and brotha, check out this below FDA Classification for a mere Class I device: hard core radiation therapy i guess can even be classified as a Class I by the FDA:


SUBCHAPTER H--MEDICAL DEVICES
PART 892 -- RADIOLOGY DEVICES

Subpart F--Therapeutic Devices

Sec. 892.5740 Radionuclide teletherapy source.
(a) Identification. A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5740



Thanks for your concern ! It just made me DD even more, and seeing alllllll these FDA Class II listings (and many more on FDA site in Class II in all kinds of complex categories and procedures - too many to list but browse through the FDA site when you get a chance) -- HAS ME MORE CONVINCED then ever that ADMD can also get Class II: FITS RIGHT IN WITH ALL THE ABOVE, eh?