Proper FDA Classification for a DICOM Viewer

c.mitch

Quite Involved in Discussions
#11
Hello Sagai,

Once again sorry to answer late. Better than never.
100% aggree with you that the sampling based on my own experience doesn't enforce the classification of software. I just wanted to show that class C is not systematic for DICOM viewer.

bye.
 
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cmeby

Involved In Discussions
#12
Hello
Just came across this thread, and maybe can provide some extra help since it was recent.
Our product is a DICOM viewer. It is classified as ClassII for FDA.
Some of the other DICOM viewers are classified as Class I for FDA.
The reason and difference is the Intended Use and the quality of the images you are showing. (evaluate Lossy and Lossless as part of this)

If your device is intended for 'Diagnostic Use'...it is Class II.
If your device is intended for 'Reference and Referral Only' (where the diagnosis is still done using the PACS workstation)...it is Class I.

Another item of issue is Measurement function. If you do use measurement it will change your classification in most countries. In EU and TGA this is a special case. 'Class I software with measuring'
 

c.mitch

Quite Involved in Discussions
#13
Thank you cmeby.

Just another information about measurement: computing roi, voi or other geometric or statistical data is not a measurement function.
Justification: the measurement is done by the imager when it acquires the modality. The dicom viewer doesn't measure but processes data (with simple or complex maths) to generate new data.
So in EU, a simple dicom viewer is class I, not Im.
 

sagai

Quite Involved in Discussions
#14
I should write :eek:

Diagnostic purpose is information only to determine that you have a medical device based on the Food Drug and Cosmetic Act.
It has nothing to do the with classification, sorry. This information neither determine the class nor any product code, classification CFR, etc.

I kindly suggest the following public information sources to take into consideration, when sharing such information on a public domain like this forum.

CDRH Learn

On the page, please consider the Overview of Regulatory Requirements: Medical Devices training and the others relating to this subject.

I think all of us have a responsibility to declare, define, share and communicate only the information we absolutely sure in order to prevent rumors, fictions and almost "religious" beliefs rolling over planet earth.

Cheers!
 
Last edited:

cmeby

Involved In Discussions
#15
My information on classification came straight from the FDA themselves during discussions about the medical imaging device and its intended use.
So I did not think sharing this information that could not be found in the online documents would be wrong. I was trying to be helpful and save someone in the industry some time. (the answer cannot be found in CDRH Learn)

Respectfully sir, in the scenario of medical image viewing, 'diagnostic usage' is referring to the radiologist using the images to make their diagnosis. Therefore the images must be of a certain quality in order to qualify as such.

A viewer that is not intended for 'Diagnostic use' can be classified according to the guidance as Class I. It is just sharing images - compressed or not and not of a quality that can assure the radiologist they can use them for diagnostic decisions.
They are considered for Reference and Referral Only and have to be marketed as such.
 

cmeby

Involved In Discussions
#16
Thank you VERY much c.mitch!!!
This is indeed the case...and has caused confusion for us as we try to classify our device for CE.
Your help is appreciated.
And so is your delivery of correction about the measuring function in such a humble and polite way :)
 

sagai

Quite Involved in Discussions
#17
My caveat was for this content you have shared.
If your device is intended for 'Diagnostic Use'...it is Class II.
and its still exist.
Diagnostic use does not mandate that the device is Class II, it mandates the device is a medical device.
Cheers
 

cmeby

Involved In Discussions
#18
You took the statement out of context and read as you want to read.

The original poster Sorcerer was asking why some viewers are Class I and some viewers are Class II when he was looking for predicate devices.

When it comes to medical image viewer, the intended use makes the difference between these classes.

The intended usage including the ability to diagnose based on the images:
known in the industry as radiological "Diagnostic Use" medical viewer. These are Class II viewers.
The intended usage for 'Reference and Referral' only are Class I viewers.

This is simple information provided to me by the FDA, and coincidentally is the same for Health Canada.

Why you decided to 'skewer me' and suggest I am spreading mis-information? Or that I go back to the basic training - I cannot take a guess. But as a newer user on this forum it makes me more hesitant to share information in the future when there are people like you out there.

And don't sign your message 'cheers' unless it is an apology. It is patronizing.
 

sagai

Quite Involved in Discussions
#19
You guy kidding with me :tg: it is not personal stuff.
I have added the value may help the kind audience.
Cheers!
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#20
You took the statement out of context and read as you want to read.

The original poster Sorcerer was asking why some viewers are Class I and some viewers are Class II when he was looking for predicate devices.

When it comes to medical image viewer, the intended use makes the difference between these classes.

The intended usage including the ability to diagnose based on the images:
known in the industry as radiological "Diagnostic Use" medical viewer. These are Class II viewers.
The intended usage for 'Reference and Referral' only are Class I viewers.

This is simple information provided to me by the FDA, and coincidentally is the same for Health Canada.

Why you decided to 'skewer me' and suggest I am spreading mis-information? Or that I go back to the basic training - I cannot take a guess. But as a newer user on this forum it makes me more hesitant to share information in the future when there are people like you out there.

And don't sign your message 'cheers' unless it is an apology. It is patronizing.
Hi,

Don't stress too much. If you have useful content that you're confident about and willing to share - please continue to share. I'm sure that there will always be someone who will appreciate it / be benefited by it. I appreciate it. There are many participants around and they all have their personal views and styles, but until further notice this is a private website and only the owner (Marc) or anyone he delegates authority to, has the right to rule out anything we write here. Each and every user will do their own math when they use whatever advice they pick up here. I certainly won't rely on a single unofficial source when making critical decisions. Heck, I don't even trust myself!...:lol:

Take it easy and thanks again for sharing.

Regards...
Ronen.
 
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