(67 days)
Not Found
No
The summary describes image processing, coregistration, segmentation, and measurement features, but does not mention AI or ML.
No.
The device is used for image review, manipulation, analysis, and planning, assisting clinicians in assessing and documenting changes, which are diagnostic and monitoring functions, not therapeutic.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device "Assists medical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning". It also mentions "Detailed measurement and reporting features assist clinicians in assessing and documenting changes in regions of interest such as pathologies".
Yes
The device is described as "software products" that can be used as "standalone applications" or "plugged in" to other applications. The description focuses entirely on the software's image processing, analysis, and reporting capabilities, with no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The description clearly states that the device processes and analyzes medical imaging data (functional MRI, PET, SPECT, CT, etc.). It manipulates, reviews, and compares these images for diagnostic review and therapy planning.
- The intended use focuses on image interpretation and analysis: The intended use describes image review, manipulation, analysis, and therapy planning based on medical images, not the analysis of biological samples.
Therefore, while this device is a medical device used for diagnostic purposes, it falls under the category of medical image processing and analysis software, not an In Vitro Diagnostic.
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.
Diagnostic Review Workstations - Assists medical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning through the flexible and interactive manipulation of multi-modality softcopy images.
Two and three-dimensional image coregistration (fusion) and segmentation of multiple imaging modality data including but not limited to functional MRI, PET, SPECT, and CT for user-selected regions of interest taken at different time points or generated using different scanning protocols.
Detailed measurement and reporting features assist clinicians in assessing and documenting changes in regions of interest such as pathologies (c.g., tumors, abscesses, AVMs). or other anatomical structures. The software can help track changes in morphology. functional activity, or other responses that may occur as a result of treatment therapy or disease progression.
Product codes
LLZ
Device Description
The Cedara I-Response and Cedara PET/CT software products are line extensions to Cedara's medical image processing workstation product, Cedara I-SoftView™. The products are designed to facilitate the oncology or other clinical specialty workflow by comparing medical imaging data from different modalities and/or from different time points. The products are able to coregister functional MRI, PET, SPECT, CT, or other modality datasets. segment out Regions of Interest (ROI), and calculate, display, and report relative differences in Apparent Diffusion Coefficient (ADC). Standardized Update Value (SUV), or other values within those regions.
The products can be used as standalone applications or can be "plugged in" and launched from within other applications such as Cedara I-SoftView, or from another workstation or console.
Mentions image processing
Medical image processing software
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
functional MRI, PET, SPECT, CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists
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)
Cedara I-SoftView, 510(k) No. K040468, Siemens syngo TrueD, 510(k) No. K041484
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
November 25, 2005
Image /page/0/Picture/2 description: The image shows a logo with the word "CEDARA" in block letters below a circular graphic. The graphic is composed of several horizontal lines that curve slightly to suggest a sphere or globe. The lines are thicker in the middle and taper off towards the edges, creating a sense of depth.
5. 510(k) Summary
| FEB 3 | 2006 | ||
|---|---|---|---|
| Submitter: | Cedara Software Corp. | ||
| Address: | 6509 Airport Road | ||
| Mississauga, Ontario | |||
| Canada L4V 1S7 | |||
| Contact: | Carol Nakagawa | ||
| Telephone: | (905) 672-2100 | ||
| Date: | November 25, 2005 | ||
| Trade Names: | Cedara I-Response™; Cedara PET/CT™ | ||
| Common Name: | Medical image processing software | ||
| Classification Name: Picture archiving and communications system | |||
| Predicate Devices: | Cedara I-SoftView, 510(k) No. K040468 | ||
| Siemens syngo TrueD, 510(k) No. K041484 | |||
| Device Description: | The Cedara I-Response and Cedara PET/CT software products are | ||
| line extensions to Cedara's medical image processing workstation | |||
| product, Cedara I-SoftView™. The products are designed to | |||
| facilitate the oncology or other clinical specialty workflow by | |||
| comparing medical imaging data from different modalities and/or | |||
| from different time points. The products are able to coregister | |||
| functional MRI, PET, SPECT, CT, or other modality datasets. | |||
| segment out Regions of Interest (ROI), and calculate, display, and | |||
| report relative differences in Apparent Diffusion Coefficient | |||
| (ADC). Standardized Update Value (SUV), or other values within | |||
| those regions. | |||
| The products can be used as standalone applications or can be | |||
| "plugged in" and launched from within other applications such as | |||
| Cedara I-SoftView, or from another workstation or console. | |||
| 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. | |||
| Diagnostic Review Workstations - Assists medical professionals |
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized globe made of horizontal lines at the top. The lines vary in length, creating a sense of depth and curvature. Below the globe, the word "CCDANA" is written in a simple, sans-serif font. The logo appears to be for an organization or company with the name CCDANA.
516(k) Premarket Notification Coura I Kesponse 1 " and Cedara PF F C F P Submiter Cedara Software Corp November 25, 2005
including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning through the flexible and interactive manipulation of multi-modality softcopy images.
Two and three-dimensional image coregistration (fusion) and segmentation of multiple imaging modality data including but not limited to functional MRI. PET. SPECT. and CT for user-selected regions of interest taken at different time points or generated using different scanning protocols.
Detailed measurement and reporting features assist clinicians in assessing and documenting changes in regions of interest such as pathologies (c.g., tumors, abscesses, AVMs). or other anatomical structures. The software can help track changes in morphology. functional activity, or other responses that may occur as a result of treatment therapy or disease progression.
Comparison to Predicate:
The intended use and technological characteristics of Cedara I-Response and Cedara PET/CT software are substantially equivalent. in the opinion of Cedara Software Corp.. to those of the predicate devices and do not pose any new issues of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above two wavy lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carol Nakagawa, B.Sc., RAC Sr. Manager, Quality and Regulatory Cedara Software Corp. 6509 Airport Road Mississauga, Ontario, L4V 1S7 CANADA
Re: K053301
FEB 3
2006
Trade/Device Name: Cedara I-Response™ and Cedara PET/CTTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: November 25, 2005 Received: November 28, 2005
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 (Premarket Approval), 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
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Nancy C. Brigdon
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
510(k) Number (if known):
Device Name:
K053301 Cedara I-ResponseTM and Cedara PET/CTTM
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.
Diagnostic Review Workstations - Assists mcdical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning through the flexible and interactive manipelation of multi-modality softcopy images.
Two and three-dimensional image coregistration (fusion) and segmentation of multiple imaging modality data including but not limited to functional MRI, PET, SPFCT, and CT for user-selected regions of interest taken at different time points or generated using different scanning protocols.
Detailed measurement and reporting features assist clinicians in assessing and documenting changes in regions of interest such as pathologics (c.g., tumors, abscesses, A VMs), or other anatomical structures. The software can help track changes in morphology, functional activity, or other responses that may occur as a result of treatment therapy or disease progression.
区 Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aarongl. Bragdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053301
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