(14 days)
Not Found
No
The description focuses on standard image registration and fusion techniques (rigid registration) and does not mention AI, ML, or related concepts. The performance studies are limited to compatibility testing, not validation of algorithmic performance typically associated with AI/ML.
No
The device is described as an image analysis software package that assists in visualizing and comparing medical images, not in treating patients.
Yes
The "Intended Use / Indications for Use" section explicitly states that the application "can assist the user in visually matching and comparing anatomical studies... as well as assist in making measurements" and "It is primarily used in the fields of diagnostic radiology, neurology and oncology." These functions are consistent with aiding in the diagnostic process.
Yes
The device is described as a "PACS plug-in (accessory)" and an "image analysis software package" that "runs on Agfa's PACS workstations". The description focuses entirely on the software's functionality in processing and displaying medical images, with no mention of accompanying hardware components developed or provided as part of this specific device submission. The performance study also focuses on compatibility with existing PACS systems, further indicating a software-only nature.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an "image analysis software package" that works with medical images (PET, MR, CT). It performs "registration and fusion" of these images to assist in visualization and comparison.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its input is medical imaging data, not biological specimens.
- Intended Use: The intended use is for "simultaneous visualization of multiple medical images," "visually matching and comparing anatomical studies," and "making measurements" based on these images. This is a function related to image processing and analysis, not in vitro testing.
Therefore, this device falls under the category of medical imaging software or image analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Registration and Fusion (Basic and Extended) are intended for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Medical Data Registration and Fusion R 1.0 is a PACS plug-in (accessory). It is an image analysis software package that establishes the geometrical relationship between different DICOM 3.0 compliant 3-D medical data sets from PET, MR and CT imaging (registration").
The matched images are displayed (fusion') by either the use of semitransparent overlays or by displaying them side-by-side.
Registration and fusion facilitates the comparison of PET/CT, PET/MRI, CT/CT, MRI/MRI, CT/MRI image data sets for use in:
- The general radiology department for various lesions. ●
- The oncology department for various cancerous lesions. .
Definitions
Image Registration: The alignment of one or more [medical] images to a reference image in order to facilitate geometric comparison. This is a numerical operation that results in the computation of an explicit mathematical transformation between every point in the registered image sets.
mage Fusion: Registration forms the basis of image fusion in the sense that the geometrical alignment of images is a prerequisite. The notion of "fusion" takes this a step further by considering how to visualize the ttent of different images representing the same object [organ, anatomical region, etc.]. Such techniques include the use of overlays, semi-transparent renderings, etc.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, MR, CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to radiologists, referring physicians, radiation therapists, and physicists. Registration may also be used by radiographers for use of the images by radiologists. Registration and fusion has application in general radiology, oncology and neurology.
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)
Registration and Fusion has been tested for compatibility with Agfa's Impax® PACS Systems.
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).
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K080013
pg. 1 of 3
510(k) Summary
Agfa Registration and Fusion
Common/Classification Name: Picture Archiving and Communications System (PACS), 21 CFR 892.2050 Proprietary Name: Registration and Fusion
Agfa HealthCare Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Tom Holbrook, Prepared: November 9, 2007 Telephone: (519) 746-6210 ext. 3297 Facsimile: (519) 746-3745
JAN 17 2008
A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's Registration and Fusion software. The predicate device, Mirage 5.5 (K043441), manufactured by Segami Corporation.
The new device is similar in indications and intended use as the predicate device.
DEVICE DESCRIPTION B.
Medical Data Registration and Fusion R 1.0 is a PACS plug-in (accessory). It is an image analysis software package that establishes the geometrical relationship between different DICOM 3.0 compliant 3-D medical data sets from PET, MR and CT imaging (registration").
The matched images are displayed (fusion') by either the use of semitransparent overlays or by displaying them side-by-side.
Registration and fusion facilitates the comparison of PET/CT, PET/MRI, CT/CT, MRI/MRI, CT/MRI image data sets for use in:
- The general radiology department for various lesions. ●
- The oncology department for various cancerous lesions. .
Definitions
Image Registration: The alignment of one or more [medical] images to a reference image in order to facilitate geometric comparison. This is a numerical operation that results in the computation of an explicit mathematical transformation between every point in the registered image sets.
mage Fusion: Registration forms the basis of image fusion in the sense that the geometrical alignment of images is a prerequisite. The notion of "fusion" takes this a step further by considering how to visualize the ttent of different images representing the same object [organ, anatomical region, etc.]. Such techniques include the use of overlays, semi-transparent renderings, etc.
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K080013
pg-2 of 3
- The neurology department for various lesions. .
The rigid registration used in the application, aims to help the clinician navigate to the same anatomical location in both image sets.
The Medical Data Registration and Fusion software runs on Agfa's PACS workstations (Impax 5.3 and 6.3 workstations).
Typical users of this system are trained professionals, including but not limited to radiologists, referring physicians, radiation therapists, and physicists. Registration may also be used by radiographers for use of the images by radiologists. Registration and fusion has application in general radiology, oncology and neurology.
C. INTENDED USE
Registration and Fusion (Basic and Extended) are intended for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's Registration and Fusion Software has similar indications and intended use as the legally marketed predicate devices.
The differences do not modify the intended diagnostic or therapeutic effect. It is intended for registering and fusing volumetric medical image data sets for the purpose of diagnosis and treatment follow-up.
Registration and Fusion is used primarily in the fields of general radiology department for various lesions, oncology for various cancerous lesions and neurology for various lesions.
Descriptive characteristics and data provided in this submission are sufficiently precise to assure substantial equivalence.
ய் TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are the same in the proposed and predicate device. All devices use similar, commercially available, computers with Windows® operating systems. All operate on DICOM images. All provide rigid registration of CT, MR and PET image data sets
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K080013
PG. 3 of 3
and SUV / Image intensity quantification.
F. TESTING
Registration and Fusion has been tested for compatibility with Agfa's Impax® PACS Systems.
G. CONCLUSIONS
This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized representation of three wavy lines, which are meant to symbolize the department's mission of promoting health and well-being. The seal is simple and recognizable, and it is used on official documents and materials produced by the HHS.
Public Health Service
JAN 17 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Agfa HealthCare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K080013
Trade/Device Name: Registration and Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 2, 2007 Received: January 3, 2007
Dear Mr. Job:
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.
4
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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. B rogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): Koloo13
Device Name: Registration and Fusion Indications for Use:
Registration and Fusion (Basic and Extended) is indicated for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arrih Whang
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number