(59 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on image review, manipulation, and workflow enhancements, not AI-driven analysis.
No.
The device is described as a medical image review workstation software designed for image review, manipulation, analysis, and planning, specifically mentioning diagnostic review and planning functions for radiologists and surgeons. It does not perform any therapeutic intervention or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning...". The "Device Description" also mentions "measurements that are commonly required for diagnosis".
Yes
The device description explicitly states "Cedara I-ReadMammo is medical image review workstation software" and describes its features as software-based image review, manipulation, and analysis. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a medical image review workstation software. Its purpose is to review, manipulate, analyze, and plan based on medical images (like X-rays, CT scans, mammograms, etc.). It does not involve testing biological samples.
- Intended Use: The intended use focuses on image management, display, review, and planning using existing medical images.
- Device Description: The description reinforces that it's software for viewing and working with medical images.
Therefore, this device falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
"Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital.
Productivity-Enhancing Second Console Workstations - Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians.
Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images including the use of prosthetic template overlays, and including mammography.
Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)
Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography."
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
Cedara I-ReadMammo is medical image review workstation software that is comprised of features that are previously cleared in Cedara I-SoftView. The differences lie mainly in workflow and user interface that make mammography image viewing more convenient for the user. The product consists of features that allow the qualified medical professional to view patient medical images with the desired viewing protocol and workflow in order to optimize the efficient use of their time. Additionally, as with all Cedara I-SoftView offerings, measurements that are commonly required for diagnosis and surgical planning are available to the user.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-modality softcopy images, mammographic images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professional, radiologists and surgeons, physicians; within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo for CEDARA. The logo consists of a stylized globe made up of horizontal lines. Below the globe is the word "CEDARA" in a bold, sans-serif font.
Special 510(k) Premarket Notification
Cedara I-SoftViews I-SoftViews
KO40468
510 (k) Summary
| Submitter: | Cedara Software Corp. |
|---|---|
| Address: | 6509 Airport Road |
| Mississauga, Ontario | |
| Canada L4V 1S7 | |
| Contact: | Carol Nakagawa. |
| Telephone: | (905) 672-2100. |
| Date: | February 2004. |
| Trade Names: | Cedara I-SoftView; Cedara I-ReadMammo |
| Common Name: | PACS medical imaging software |
| Classification Name: | Picture archiving and communications system. |
| Cleared Devices: | Cedara Software Corp., Cedara I SoftView, 510(k) No. K022881. |
| Device Description: | Cedara I-ReadMammo is medical image review workstation |
| software that is comprised of features that are previously cleared in | |
| Cedara I-SoftView. The differences lie mainly in workflow and | |
| user interface that make mammography image viewing more | |
| convenient for the user. The product consists of features that allow | |
| the qualified medical professional to view patient medical images | |
| with the desired viewing protocol and workflow in order to | |
| optimize the efficient use of their time. Additionally, as with all | |
| Cedara I-SoftView offerings, measurements that are commonly | |
| required for diagnosis and surgical planning are available to the | |
| user. |
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Image /page/1/Picture/0 description: The image shows a logo with the word "CEDARA" in bold, sans-serif font at the bottom. Above the text is a circular graphic made up of many horizontal lines. The lines are closely spaced together, creating a textured effect within the circle.
Indications for Use:
"Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital.
Productivity-Enhancing Second Console Workstations - Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians.
Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images including the use of prosthetic template overlays, and including mammography.
Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)
Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography."
Comparison to Previously Cleared Device:
The intended use and technological characteristics of Cedara I-ReadMammo Workstation software are substantially equivalent, in the opinion of Cedara Software Corp. to those of the previously cleared device and do not pose any new issues of safety and effectiveness.
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2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2004
Ms. Carol Nakagawa Manager of Regulatory Affairs Cedara Software Corp. 6509 Airport Road Mississauga Ontario, L4V 1S7 CANADA
Re: K040468
Trade/Device Name: Cedara I-SoftView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: April 6, 2004 Received: April 7, 2004
Dear Ms. Nakagawa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number | K040468 |
|---|---|
| Device Name | Cedara I-SoftView |
| Indications for Use | "Two and three dimensional image review, manipulation, analysis and |
| therapy planning capabilities that support image management display | |
| needs in the medical environment from multiple locations within and | |
| outside the hospital. |
Productivity-Enhancing Second Console Workstations - Workstations
designed to perform automated, routine tasks such as image review,
printing and archiving as well as post processing capabilities that enable
special services for referring physicians.
Diagnostic Review Workstations - Workstations designed to assist
radiologists and surgeons in conducting primary diagnostic review and
planning through flexible and interactive manipulation of multi-modality
softcopy images including the use of prosthetic template overlays, and
including mammography.
Physician's Review Workstations - Workstations designed to give easy and
economic access to multi-modality softcopy images in multiple locations
within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)
Lossy compressed mammographic images must not be used for primary
diagnostic interpretation unless approved for use in digital
mammography. Display monitors used for primary diagnostic
interpretation of mammographic images must be approved for use in
digital mammography." |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
..__________________________________________________________________________________________________________________________________________________________________________
... ..
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801. 109) | |
|---|---|
| ---------------------------------------- | ------------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K040468 |