(81 days)
Not Found
Not Found
No
The description focuses on standard image viewing and manipulation features, with no mention of AI, ML, or related concepts like automated analysis or pattern recognition beyond basic filtering.
No.
The KIMAX™ Remote Viewing Station is intended for viewing and manipulating medical images for diagnostic purposes, not for treating or providing therapy to a patient.
No
Explanation: The device is intended for viewing and processing medical images, not for diagnosing conditions or making medical interpretations. While it aids physicians, it does not perform diagnostic functions itself.
No
The device description explicitly states that the KIMAX ™ Remote Viewing Station includes both software and hardware components (high-performance computer, data storage devices, high-resolution monitor).
Based on the provided information, the KIMAX ™ Remote Viewing Station (RVS) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The RVS is used to view and manipulate digital images from medical imaging equipment (like radiographic images). It does not interact with or analyze biological samples.
- The intended use is for viewing and manipulating medical images. The description clearly states its purpose is to allow physicians to view, adjust, and annotate images from imaging equipment. This is a function related to image display and processing, not diagnostic testing of biological samples.
Therefore, the RVS falls under the category of medical imaging software and hardware, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The KIMAX ™ Remote Viewing Station software and hardware (RVS) are intended to allow physicians to view static or dynamic digital images from radiographic and other medical imaging equipment. The RVS includes a high-performance computer, data storage devices, a high-resolution monitor and software to: 1) accept AVI images or import other image formats; 2) allow physician to quickly locate and display images; 3) adjust contrast and brightness, apply filters to enhance the images, zoom in on selected features, pan to select reading of more of the rest, and annotate images; 4) print out selected images; and 5) create reports that include text and annotated images.
Product codes
90 LLZ
Device Description
The RVS includes a high-performance computer, data storage devices, a high-resolution monitor and software to: 1) accept AVI images or import other image formats; 2) allow physician to quickly locate and display images; 3) adjust contrast and brightness, apply filters to enhance the images, zoom in on selected features, pan to select reading of more of the rest, and annotate images; 4) print out selected images; and 5) create reports that include text and annotated images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
static or dynamic digital images from radiographic and other medical imaging equipment
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / clinical workspace
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2001
Mr. George T. Knackstedt Director Medical Metrics, Inc. 10540 Rockley Road, Suite 200 HOUSTON TX 77099
Re: K013098 K013098
Trade/Device Name: KIMAX™ Remote Viewing Station
Trade/Device Name: KIMAX™ 200 2050 TraderDevice Namber: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: August 27, 2001 Received: September 17, 2001
Dear Mr. Knackstedt:
We have reviewed your Section 510(k) premarket notification of intent to market the device
ty the indication of the said to since is substantially equivalent (for the indica We have reviewed your Section 5 IQ(k) prematice in univation in muirvalent (for the indications
referenced above and have detectived the devices is substantially equivale referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed prodicale devices marketed in interstate for use stated in the enclosure) to legally market predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactment with the provisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Rede devices that have been reclassified in accordance will the proval application (PMA).
and Cosmetic Act (Act) that do ice approval of a premalces approval application (PMA). and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to may begistration, listing of
general controls provisions of the Act include requirements for annual registrations and general controls provisions of the Act include requirements of the Groupen in Maranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into extrem confections affecting your device can be
it may be subject to additional controls. Existing major regulations affective it may be subject to additional controls. Existing major regulations and and of your of the may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In add found in the Code of Federal Regulations, Trilo 21, I accords
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
ts of the Act Please be advised that FDA's issuance of a substanted doler requires with other requirements of the Act
that FDA has made a determination that your device complies with of th that FDA has made a determinations administered by other Federal agencies. You must
or any Federal statutes and regulations anningiting by other Federal on and listi or any Federal statutes and regulations and including, but not listing the mand listing
comply with all the Act's requirements, including, but not listing requirements as comply with all the Act's requirements, finciding, our not minted to reguirements as se
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement (21 CFR Part 807); labeling (21 CFR Part 801); good manataotande for mobile, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050. forth in the quality systems (QS) regulation (21 CFR Part 25) -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1
1
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begin marketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivaler and thus nemits your d notification. The FDA finding of substantial equivalence or 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
r in the regulation If you desire specific advice for your device on our laboring agains.
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 Additionally, for questions on the promotion and and one one of essent of the mating.
Office of Compliance at (301) 594-4639. Also, please noneral information on Office of Compliance at (301) 394-4057. Also, production) Other general information of Small Manufacture by reference to premarket notification (21 Cr F r a F orision of Small Manufacturers,
your responsibilities under the Act may be obtained from the Division of Small Manufactu your responsibilities under the Act may or obtails nonemal (800) 638-2041 or (301) 443-6597
International and Consumer Assistance at 11 1 14 modemons btml International and Consumer Tissistance at the form of the main.html.
Sincerely yours,
Vernie C. Snodgin
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
2013098 510(k) Application
Medical Metrics, Inc. Medical Metrics, te Viewing Station
Statement of Intended Use 1.0
The KIMAX ™ Remote Viewing Station software and hardware (RVS) are intended
ed to the Remote with and mamic digital images from radiographic and The KIMAX ™ Remote Viewstatic or dynamic digital images from radiographic and
to allow physicians to view static or dynamic digital images from radiographic and to allow physicians to view station of dynamic digh-performance computer,
other medical imaging equipment. The RVS includes a high-performance computer, other medical imaging equipment. The R V > includes a magn-pons intended to be used
data storage devices, a high-resolution monitor and software to: l) data storage devices, a high-resolution monitor and Socware to: 1)
in the clinical workspace of a practicing physician. The RVS includes software to: 1)
Pressure of a the tha in the clinical workspace of a practicing physician: 2) allow physician to quickly
accept AVI images or import other image formats; 2) allow physician to quickly accept AVI images or import other image formals, 27 and prightsess, apply filters to enhance
locate and display images; 3) adjust contrast and brightness, apply filters to en locate and display images; 3) adjust contrast and offectures of interest, and the images, zoom in on selected teatures, pan to select reading of more of the rest
annotate images; 4) print out selected images; and 5) create reports that include text and annotated images.
Tämit le. A. yper
Prescription Use K0/3098