(67 days)
KIMAX QMA™ is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. KIMAX QMA™ permits users to review static and dynamic digital images acquired from a variety of radiographic to review static and dynamic argultative assessment of motion in radiographic .
Information obout the matiative assessment of motion in radiographic ...
Information obout th Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts and text.
KIMAX QMA™ is a quantitative imaging software application.
This section is not applicable since the provided text is a 510(k) clearance letter from the FDA, a regulatory document, and does not contain details about acceptance criteria, study methodologies, or performance metrics of a medical device. The letter primarily confirms that the device, KIMAX QMA™, is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include information on the technical studies or data that would typically prove a device meets specific acceptance criteria.
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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle symbol, with three curved lines representing the eagle's body and wings. The eagle faces to the right.
Public Health Service
02
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark Lamp President Medical Metrics, Inc 10540 Rockley Road Suite 200 HOUSTON TX 77099
Re: K022585
Trade/Device Name: KIMAX QMA™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: July 18, 2002 Received: August 5, 2002
Dear Mr. Lamp:
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, 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 (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); 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indication for Use Statement
Medical Metrics, Inc.
510K Device Number:
Product:
Sponsor:
KIMAX OMATM
Indication for Use:
Statement of Intended Use 1.0 .
KIMAX QMA™ is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. KIMAX QMA™ permits users to review static and dynamic digital images acquired from a variety of radiographic to review static and dynamic argultative assessment of motion in radiographic .
Information obout the matiative assessment of motion in radiographic ...
Information obout th Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts and text.
Prescription Use
(Per 21 CFR 801.109)
David C. Ingram
0/300/ Hugo/
(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).