MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ

K981641 · Instrumentarium Corp. · IZH · Jul 17, 1998 · Radiology

Device Facts

• Record ID: K981641
• Device Name: MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ
• Applicant: Instrumentarium Corp.
• Product Code: IZH · Radiology
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

The mammographic X-ray unit model MGF101 and MGF110, is a mammographic imaging system for screening and diagnostic examinations. The unit can also be adapted for biopsy and spot mammographic examinations.

Device Story

Mammographic X-ray system (models MGF101/MGF110; commercial names Alpha III, Alpha ST, Alpha RT, Alpha IQ) used for breast imaging. Device captures X-ray images for screening, diagnostic, biopsy, and spot mammography. Operated by trained radiologic technologists in clinical settings. Output consists of radiographic images used by radiologists to detect breast abnormalities and guide biopsy procedures. System facilitates clinical decision-making regarding breast health and diagnostic follow-up.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mammographic X-ray imaging system. Class II device (21 CFR 892.1710).

Indications for Use

Indicated for screening and diagnostic mammographic examinations, including biopsy and spot mammographic procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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-