SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM
Applicant
Areeda Assoc., Ltd.
Product Code
LLZ · Radiology
Decision Date
Dec 12, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The SeeMor™ software program should be used for the display and image manipulation of multimodality diagnostic medical images. The intended use of this program was to provide the physician with a display program which would allow for the remote viewing and interpretation of medical images. This program serves merely as a display program to aid in the diagnostic interpretation of a patients' study. It does not provide any diagnostic interpretive output other than the display of the images. Therefore, this program has no direct adverse effect on health since it is only providing a means of displaying the medical images for the physician. The final responsibility for interpretation of the study lies with the physician.
Device Story
SeeMor™ is a software program for personal computers (IBM PC or Macintosh) designed for viewing and manipulating diagnostic medical images. It accepts medical image data as input and provides tools for image processing, including clipping, window/level adjustment, magnification, pan, relate, add, delete, next, cine, lock, select, view, flip, color table adjustment, and orthogonal view reconstruction. The device is intended for use by physicians in clinical settings to facilitate remote viewing and interpretation of patient studies. It does not provide automated diagnostic interpretation; the physician retains final responsibility for clinical decision-making based on the displayed images. The software aims to improve diagnostic workflow by providing a non-proprietary platform for image review.
Clinical Evidence
In-house trial validation conducted on 25 patients to establish effectiveness. No clinical prospective or retrospective studies reported. Bench testing included design, coding, debugging, and validation.
Technological Characteristics
Software-based medical imaging display program. Executes on non-proprietary hardware (IBM PC or Macintosh). Provides image manipulation tools (clipping, window/level, magnification, pan, cine, orthogonal reconstruction).
Indications for Use
Indicated for the display and manipulation of multimodality diagnostic medical images to aid physicians in remote viewing and interpretation of patient studies.
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).
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# ITEM I
K973653 ×973653
# 510(k) SUMMARY
DEC 1 2 1997
## Safety and Effectiveness
#### 1. Medical Device Establishment
Areeda Associates Ltd 516 N. Curson Avenue Los Angeles, CA 90036 Voice: (213) 653-5515 (213) 653-5514 FAX: e-mail: joe@areeda.com Contact person: Joseph Areeda or Kenneth Van Train Date Summary Prepared: September 24, 1997
#### 2. Medical Device:
SeeMor™ - Medical Imaging Display & Processing program executing on personal computer systems.
### 3. Medical Device Equivalence:
MedVision™ Imaging Software developed by Evergreen Technologies, Inc., Ref. 510(k) #: K924178.
#### 4. Device Description:
This medical device (SeeMor™) is a display program for viewing diagnostic medical images. The program provides the capabilities of manipulating the images being displayed with the following command options: clipping, window/level adjustment, magnification, pan, relate, add, delete, next, cine, lock, select, view, flip vertical/horizontal, set color table, orthogonal view reconstruction, cascade, tile, and reset.
### 5. Intended Use and Potential Adverse Effect on Health:
The intended use of this program was to provide the physician with a display program which would allow for the remote viewing and interpretation of
{1}------------------------------------------------
medical images. This program serves merely as a display program to aid in the diagnostic interpretation of a patients' study. It does not provide any diagnostic interpretive output other than the display of the images. Therefore, this program has no direct adverse effect on health since it is only providing a means of displaying the medical images for the physician. The final responsibility for interpretation of the study lies with the physician.
### 6. Marketing History:
There have been multiple medical device display programs marketed in the past which perform similar functions to those performed by SeeMor™. These programs are all used for the sole purpose of displaying medical images for the diagnostic interpretation by a physician. The SeeMor™ program provides a program which executes on non-propriety hardware (IBM PC or Macintosh) and we believe is substantially equivalent to the MedVision Viewer developed by Evergreen Medical Technologies K924178. To our knowledge there have been no safety problems with the MedVision Viewer medical display program which has been in the marketplace for over four years. In addition, we are not aware of any problems on any of the proprietary medical display programs which have been in the marketplace for over 20 years.
### 7. Conclusions:
The safety of this program has been determined through the various stages of software development which included the initial design, coding, debugging, testing, and in-house validation. The effectiveness of the program has been established in an in-house trial validation which included an evaluation of 25 patients. We contend that the method employed for the development and the final in-house trial validation results of this medical display software program (SeeMor™) have proven its safety and effectiveness.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human figures in profile, with flowing lines suggesting movement or connection.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
DEC | 2 |997
Joseph Areeda President Areeda Associates, Ltd. 516 N. Curson Ave. Los Angeles, CA 90036-1814 Re:
K973653 SeeMor™ (Image Processing System) Dated: September 24, 1997 Received: September 25, 1997 Regulatory class: Unclassified Procode: 90 LLZ
Dear Mr. Areeda:
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 misbranion.
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 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 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 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 question 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/cdrh/dsmamain.html".
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D.
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
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510(k) Number (if known): ___K973653
Device Name: _________________________________________________________________________________________________________________________________________________________________ Personal Computers
Indications For Use:
The SeeMor™ software program should be used for the display and image manipulation of multimodality diagnostic medical images.
(PLEASE DO NOT WRITE BELOW THIS UNE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ 1 (Per 21 CER 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Willian Y
(Division Sign-Off) (Division Sign-Off)
Division of Denductive, Abdominal, ENT, and Rachelogical Devices
510(k) Number _
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Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
