MACOM

K973148 · A.Stein - Regulatory Affairs Consulting · LLZ · Nov 20, 1997 · Radiology

Device Facts

• Record ID: K973148
• Device Name: MACOM
• Applicant: A.Stein - Regulatory Affairs Consulting
• Product Code: LLZ · Radiology
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MACOM ™ performs real-time digital image enhancement of screen/film mammograms.

Device Story

MACOM™ Image Processing System performs real-time digital image enhancement of screen/film mammograms. Device processes analog mammographic images to improve visualization; assists clinicians in diagnostic review. Used in clinical settings by radiologists/technicians. Output provides enhanced image quality for clinical decision-making; potentially improves diagnostic accuracy by clarifying mammographic features.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital image processing system for screen/film mammograms. Real-time enhancement functionality.

Indications for Use

Indicated for real-time digital image enhancement of screen/film mammograms.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Sophisview Technologies. Ltd. c/o Ahava Stein Regulatory Affairs Consulting POB 454 Ginot Shomron 44853 Israel

Re: K973148

> MACOM™ Image Processing System Dated: July 30, 1997 Received: August 22, 1997 Regulatory class: Unclassified Procode: 90 LLZ

Dear Ms. Stein:

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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 ise 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, 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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 conceming 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 531 through 542 of the Act for devices under 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 marked 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 809.00 for in yitre. . diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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/cdrh/dsmamain.html".

Sincerely yours,

W.Liau Yu

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

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## Indications for Use Statement

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| 510(k) Number (if known): | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------- |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

MACOM™ Image Processing System Device Name:

MACOM ™ performs real-time digital image enhancement Indications for use: of screen/film mammograms.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. de yong

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 4973148 510(k) Number

OR

Prescription Use V (Per 21 C.F.R. 801.109) Over-The-Counter Use (Optional Format 1-2-96)