(165 days)
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.
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.
The provided document is an FDA 510(k) clearance letter for the iCRco Clarity Viewer, which is a Picture Archiving and Communications System (PACS). This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a 510(k) submission's performance section.
The letter confirms substantial equivalence but does not provide the specifics of the studies conducted to demonstrate that equivalence. The information requested regarding acceptance criteria, sample sizes, expert qualifications, ground truth, and specific study designs (MRMC, standalone) is not present in this document.
The document only states the "Indications For Use" and general device function:
- Device Name: Clarity Viewer
- Indications For Use: Software that retrieves digital images and data from various sources (e.g., CT, MR, ultrasound, R/F, computed & direct radiographic devices, secondary capture, 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.
- Compression: Utilizes lossless algorithms for compression services (JLS, J2KR, and JPLL). Lossless compressed mammographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images from outside sources and digitized film screen images must not be reviewed for primary image interpretation.
- Mammography Interpretation Requirement: 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.
To answer the questions posed, the actual 510(k) submission document (K132499) would need to be consulted, specifically the sections detailing the performance studies and bench testing. This clearance letter is merely the FDA's decision based on that submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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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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§ 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).