(119 days)
The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems products are intended to be used by healthcare professionals as a radiological image acquisition, storage, and routing system for remote acquisition and transmission of diagnostic images.
The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems
My apologies, but the provided text does not contain the specific information required to complete your request. The document is an FDA 510(k) clearance letter for a teleradiology system, detailing its substantial equivalence to previously marketed devices and its indications for use.
It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number of experts for ground truth, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or details about training sets.
Therefore, I cannot extract the requested information from the given text.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three wavy lines that represent the three levels of government: federal, state, and local. The words "DEPARTMENT OF" are written vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Access Radiology Corporation c/o Alan M. Green, M.D., Ph.D., J.D. M.L. Strategies, Inc. One Financial Center Boston, MA 02111
Re: K972925
Access Radiology (Framewave) Teleradiology Image Acquisition and Distribution System with (PACS) Picture Archiving and Communications System Dated: November 13, 1997 Received: November 14, 1997 Unclassified/Procode: 90 LMD
DEC = 5 1997
Dear Dr. Green:
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 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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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,
h7liau 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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510 (k) Number (if known): K972925 Device Name: The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems
INDICATIONS FOR USE:
The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems products are intended to be used by healthcare professionals as a radiological image acquisition, storage, and routing system for remote acquisition and transmission of diagnostic images.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shind A. Seymm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1972925 510(k) Number
Prescription Use_ V (Per 21 CFR 801.109)
OR
Over-The-Counter (Optional Format 1-2-96)
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.