(70 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No
The device is described as a "mammographic imaging system for screening and diagnostic examinations," which indicates it is used for imaging and diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section states that it is a "mammographic imaging system for screening and diagnostic examinations."
No
The device description explicitly states it is "Mammography X-ray equipment models MGF101 and MGF110," which are hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body. They are used to diagnose diseases or conditions based on the analysis of these samples.
- This device is a mammographic X-ray unit. It is used to create images of the breast inside the body using X-rays. This is an in vivo imaging technique, not an in vitro diagnostic technique.
The description clearly states its purpose is for "mammographic imaging system for screening and diagnostic examinations" and "biopsy and spot mammographic examinations," all of which involve imaging the body directly.
N/A
Intended Use / Indications for Use
The mammographic X-ray unit model MGF101 and MGF110, is a The mammographic imaging system for screening and diagnostic examinations. The unit can also be adapted for biopsy and spot mammographic examinations.
Product codes (comma separated list FDA assigned to the subject device)
90 IZH
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
X-ray
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 1998
Instrumentarium Corp. Imaging Div. c/o Instrumentarium Imaging Inc. 300 West Edgerton Avenue Milwaukee, WI 53207 Attn: Max Lindert
Re:
K981641 Alpha III, Alpha ST, Alpha RT and Alpha IQ Dated: April 28, 1998 Received: May 8, 1998 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. Lindert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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 Device Amendments, or to 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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 542 of the Act for derices 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 predicate device results in a classification 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 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 entitled, "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/cdch/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
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Image /page/1/Picture/1 description: The image shows the logo for Instrumentarium Imaging. The logo consists of a stylized graphic on the left, followed by the words "INSTRUMENTARIUM" in a smaller, uppercase font, and then the word "imaging" in a larger, lowercase font. The graphic is a series of black bars that create a sense of depth and dimension.
May 19, 1998
K981641 510(k) Number:
Mammography X-ray equipment models MGF101 and MGF110, Device Name: Commercial names: Alpha III, Alpha ST, Alpha RT and Alpha IQ
Indications For Use: The mammographic X-ray unit model MGF101 and MGF110, is a 1 he manilliographic imaging system for screening and diagnostic examinations. The unit can also be adapted for biopsy and spot mammographic examinations.
Instrumentarium Corp. Imaging Division
Risto Mynttinen
Regulatory Affairs
Unid A. Seym
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
FDA/CDRH/ODE/DMC
21 May 99 09 10
Prescription Use
(Per 21 CFR 801.109)
SK-