(252 days)
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No
The summary describes a digital mammography system that generates images, but there is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies for analysis or interpretation.
No
The device is used for generating mammographic images for screening and diagnosis of breast cancer, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device is intended to be used for screening and diagnosis of breast cancer." This directly indicates its diagnostic purpose.
No
The device description explicitly states that the device comprises a "iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette," indicating the inclusion of hardware components (the cassette).
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.
- Device Function: The description clearly states that this device generates digital mammographic images using a mammographic x-ray machine. This is an in vivo imaging process, meaning it is performed on a living patient, not on a sample taken from the patient.
- Intended Use: The intended use is for screening and diagnosis of breast cancer by generating and interpreting images, not by analyzing biological samples.
Therefore, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by an MQSA qualified physician using either hardcopy film or softcopy display at a workstation.
Product codes
MUE
Device Description
The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
mammographic x-ray machine
Anatomical Site
breast
Indicated Patient Age Range
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Intended User / Care Setting
MQSA qualified physician
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three overlapping shapes that resemble human figures or abstract forms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2013
iCRco, Inc. % Mr. Greg Wachtler Manager, Regulatory Compliance 2580 West 237th Street TORRANCE-CA-90505-
Re: K122510
Trade/Device Name: iCRco 3600M Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: April 19, 2013 Received: April 24, 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. Ilsting 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.
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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.htm.
Sincerely yours,
Jamila M. Mense
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): K122510
Device Name: iCR 3600M
Indications for Use:
The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by an MQSA qualified physician using either hardcopy film or softcopy display at a workstation.
Prescription Use V (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 CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Image /page/2/Picture/10 description: The image shows a logo with the word "FLUX" in a stylized font. The letters are formed by geometric shapes, with the "F" and "L" appearing to be constructed from nested squares and the "X" from nested triangles. Above the logo, there is a signature or handwritten text that is difficult to read due to its cursive style and overlapping strokes. The overall design has a modern and somewhat abstract appearance.
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K122510 510(k)
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