[optimal] question on fundus camera conversion
- From: Dale Brodsky <dale.brodsky@xxxxxxxxx>
- To: optimal@xxxxxxxxxxxxx
- Date: Thu, 3 Feb 2011 18:39:41 -0600
Hi Dirk,
With our FDA approved Fundus Photo Imaging System, converting the 50VT with
the Canon 21 megapixel full frame 5D Mark II is easy and the images are
impressive. I will send you a note off-list with specifics.
For those that wish to learn more, just go to www.fundusphoto.com. I do
have financial interest.
On the subject of FDA approval, it is required for any attachment to a
fundus camera...period. Having just gone through the 510(k) approval
process, I can assure everyone there is no wiggle room in FDA's
interpretation of digital conversions for fundus cameras. Digital upgrades
are Class II devices and are treated exactly and identically to a complete
fundus camera, regardless of mydriatic or non-myd application. Exposure,
emissions, electrical, optics...everything. In addition, CMS rules tell us
medical equipment used for billing must be FDA approved (except for FDA
sanctioned investigative/experimental devices)..
Here is more information for doctors you work with and rely upon you for
guidance.
*Fundus Photo earns US FDA 510(k) approval.
We are the only ophthalmic digital imaging provider in this segment to
achieve the highest level of quality, safety and performance the FDA, ISO
and our customers demand.***
*Did you know?*
*CMS requires FDA approved devices for payment and FDA **reports all device
approvals to CMS**:
Medicare Benefit Policy Manual, Chapter 14 - Medical Devices, sections 10 &
80
*
Devices that may be covered under Medicare include the following categories:
• Devices approved by the FDA through the Pre-Market Approval (PMA) process;
• Devices cleared by the FDA through the 510(k) process;
• FDA-approved IDE Category B devices; and
• Hospital Institutional Review Board (IRB) approved IDE devices
Services related to the use of a non-covered device are not covered under
Medicare.
*Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Notices*
*"That is, services related to the use of a non-covered device are not
covered under Medicare. We are codifying in the regulations
a provision explaining that services related to a non-covered device
are not covered under Medicare.
These services include all services furnished in preparation for the
use of a non-covered
device, services furnished contemporaneously with and necessary to the
use of a non-covered device, and services furnished as necessary
after-care that are incident to recovery from the use of the device or
from receiving related non-covered services."*
Thanks,
Dale
Dale Brodsky
President - Fundus Photo, LLC - digital imaging for fundus cameras - FDA
Approved!
Owner - St. Louis Ophthalmic Equipment Company - in our 20th year!
3015 Locust Street St. Louis, MO 63103 USA
314.533.6000 fax 314.534.6000 Mobile 314.406.3600
Visit our websites at http://www.stleye.com and http://www.fundusphoto.com
On Thu, Feb 3, 2011 at 6:02 PM, Dirk-Uwe Bartsch <dbartsch@xxxxxxxx> wrote:
> Hi,
> I have a question about how to get an old 35mm fundus camera into the
> digital world.
>
> I have two old cameras:
> 1) Topcon TRC-50VT
> 2) Zeiss FF3
>
> Which one is easier to convert?
>
> Thanks for any advice,
>
> Dirk-Uwe
>
>
>
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