(116 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware modifications related to radiation and mA values, not software or algorithmic changes.
No
This device is for radiography (imaging) of the breast, which is a diagnostic procedure, not a therapeutic one.
Yes
The device is described as a "mammography system" with the "Intended Use" of "Radiography of the breast". Radiography is an imaging technique used for diagnosis, making the device a diagnostic tool.
No
The device description clearly states it is a "mammography system," which is a hardware device used for imaging. The modifications described relate to hardware parameters (radiation, mAs, mA values, focal spot).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Radiography of the breast," which is an imaging procedure performed on a living patient, not a test performed on a sample taken from the body.
- Device Description: The description details a mammography system, which is a medical imaging device used to produce images of the breast.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is clearly an imaging system used for diagnostic purposes through the creation of images, not through the analysis of biological samples.
N/A
Intended Use / Indications for Use
The intended use and the indications of use of the GLORY mammography system are identical to those of the MAM-CH22S mammography system. Radiography of the breast
Product codes
90 IZH
Device Description
The 510(k) premarket notification for the GLORY mammography system describes a modification of the legally marketed MAM-CH22S mammography system (K960381). Compared to the MAM-CH22S mammography system, additional radiation (or mAs) is provided for very thick or dense breasts and higher mA values are provided with the small focal spot for magnification procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
K9706.80
IIIN 20 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
The 510(k) premarket notification for the GLORY mammography system describes a modification of the legally marketed MAM-CH22S mammography system (K960381).
The intended use and the indications of use of the GLORY mammography system are identical to those of the MAM-CH22S mammography system.
The effectiveness of the GLORY mammography system is significantly equivalent to that of the MAM-CH22S mammography system. Compared to the MAM-CH22S mammography system, additional radiation (or mAs) is provided for very thick or dense breasts and higher mA values are provided with the small focal spot for magnification procedures.
With regards to safety, the GLORY mammography system was designed to comply with International Standard IEC (International Electrotechnical Commission) 601-1, Medical Electrical Equipment, Part 1: General Requirements For Safety. The modifications were analyzed and preventive measures were taken.
Based on this analysis, to the best of our judgment, the GLORY mammography system does not introduce new significant risks that could cause a safety hazard.
Based on the above, it is Elscint's opinion that the GLORY mammography system is substantially equivalent in safety and effectiveness to the legally marketed device, MAM-CH22S.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 are three stylized human figures, possibly representing individuals or families, in a flowing, abstract design.
Food and Drug Administration 9200 Corporate Coulevard Rockville MD 20850
.JUN 20 1997
Beny Sherer Safety Officer Elscint, Inc. Service Headquarters_ 86 Orchard Street Hackensack, NJ 07601 Re: K970680 Glory Mammography System Dated: May 15, 1997 Received: May 16, 1997 .. Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. Sherer:
分
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 80) and additionally 809.10 for in yritro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entilled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Y
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K970680
Device Name: GLORY Mammography System
Indications For Use:
参
ं : देश
Radiography of the breast
(Please do not write below this line-continue on another page if needed)
(Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
و . شه
Daniel L. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 70680 510(k) Number _ y g
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