(165 days)
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No
The summary describes a medical image viewer and archiving software that uses standard lossless compression algorithms. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is described as software that retrieves and displays medical images and data, for primary image interpretation, it does not directly treat or diagnose conditions.
Yes
The device is software that retrieves and displays medical images (from sources like CT, MR, ultrasound) for primary image interpretation, including mammography, which is a diagnostic process.
Yes
The device description explicitly states "Clarity Viewer is software" and describes its functions solely in terms of software operations (retrieving, displaying, archiving, compressing images and data). There is no mention of any 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.
- Clarity Viewer's Function: The description clearly states that Clarity Viewer is software that retrieves and displays digital images and data from various medical imaging modalities (CT, MR, ultrasound, etc.). It is used for viewing and interpreting these images.
- No Mention of Biological Samples: There is no mention of the device interacting with or analyzing biological samples. Its function is solely related to medical imaging data.
Therefore, Clarity Viewer falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Clarity Viewer is software that retrieves digital images and data from various sources (e-g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
Images (including mammography) and data can be retrieved and displayed within the system and or across computer networks at distributed locations.
Clarity's archiving engine utilizes lossless algorithms for compression services (JLSL, J2KR, and JPLL). Lossless compressed mammographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images received from outside sources and digitized film screen images must not be reviewed for primary image interpretation.
Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with outstretched arms, often referred to as the "Human Services Symbol." The symbol is composed of three overlapping shapes, creating a sense of movement and connection.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 21, 2014
iCRco Inc. % Mr. Greg Wachtler Manager, Regulatory Compliance 2580 West 237th Street TORRANCE CA 90505
Re: K132499
Trade/Device Name: iCRco Clarity Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 24, 2013 Received: October 25, 2013
Dear Mr. Wachtler:
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. Please note: CDRH does not evaluate information related to contract tiability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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Page 2 - Mr. Wachtler
, .
. .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K132499
Device Name: Clarity Viewer
Indications For Use:
Clarity Viewer is software that retrieves digital images and data from various sources (e-g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
Images (including mammography) and data can be retrieved and displayed within the system and or across computer networks at distributed locations.
Clarity's archiving engine utilizes lossless algorithms for compression services (JLSL, J2KR, and JPLL). Lossless compressed mammographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images received from outside sources and digitized film screen images must not be reviewed for primary image interpretation.
Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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