(101 days)
Not Found
Not Found
No
The summary describes a system for receiving, storing, communicating, processing, and displaying medical images. It mentions "image processing" but does not provide any details suggesting the use of AI/ML algorithms for interpretation, analysis, or decision support. There is no mention of AI, ML, deep learning, training data, test data, or performance metrics typically associated with AI/ML devices.
No.
The provided text describes a device that receives, stores, processes, and displays medical images for diagnostic interpretation and review, not for a therapeutic purpose.
Yes
The device is utilized for the "interpretation of mammography images in a primary diagnostic setting" and states that "for image diagnosis, this device can only be used by trained professionals."
Yes
The description focuses entirely on the software's functions (receiving, storing, communicating, processing, and displaying images and data) and its use on FDA-cleared monitors. There is no mention of any accompanying hardware components that are part of the device itself.
Based on the provided information, UniWeb™ 8.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- UniWeb™ 8.0's Function: UniWeb™ 8.0 deals with digital images and data from various medical imaging modalities (mammography, MRI, ultrasound, etc.). It stores, communicates, processes, and displays these images.
- No Specimen Analysis: The description does not mention any analysis of biological specimens. The device works with images generated by medical imaging equipment, not with samples taken from a patient's body.
Therefore, UniWeb™ 8.0 falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), which are distinct from IVD devices.
N/A
Intended Use / Indications for Use
UniWeb™ 8.0 is a device that receives digital images and data from various sources (including but not limited to Fullfield digital mammography, MR scanners, CR, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted imaging sources).Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
UniWeb™ 8.0 is utilized only on FDA cleared monitors for interpretation of mammography images in a primary diagnostic setting. Moreover, it can display FFDM(Full-field digital mammography) post-processed images in DICOM for presentation only formats. This device will only use lossless compression when displaying mammography images. For image diagnosis, this device can only be used by trained professionals. However, for image review, the users will not be limited to physicians, nurses and technicians.
Product codes
LLZ
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fullfield digital mammography, MR scanners, CR, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For image diagnosis, this device can only be used by trained professionals. However, for image review, the users will not be limited to physicians, nurses and technicians.
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
December 18, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
EBM Technologies Incorporated % Mr. John Su Quality Manager 5f., No. 516, Sec. 1, Neihu Road., Neihu Dist. Taipei. 114 TAIWAN
Re: K142514 Trade/Device Name: UniWeb™ 8.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 12, 2014 Received: November 19, 2014
Dear Mr. Su:
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 liability 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 device-related 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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/default.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 Industry and Consumer Education 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.htm.
Sincerely yours,
Robert A Ochs
Robert A. Ochs, Ph.D. Acting 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) K142514
Device Name UniWeb™ 8.0
UniWeb™ 8.0 is a device that receives digital images and data from various sources (including but not limited to Fullfield digital mammography, MR scanners, CR, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted imaging sources).Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
UniWeb™ 8.0 is utilized only on FDA cleared monitors for interpretation of mammography images in a primary diagnostic setting. Moreover, it can display FFDM(Full-field digital mammography) post-processed images in DICOM for presentation only formats. This device will only use lossless compression when displaying mammography images. For image diagnosis, this device can only be used by trained professionals. However, for image review, the users will not be limited to physicians, nurses and technicians.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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