(86 days)
The Imageshare Computed Radiography Acquisition Station and/or Software is a bi-directional gateway that sends or receives digital images to/from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation's DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.
The Imageshare Computed Radiography Acquisition and/or Software is designed to operate on a general purpose computer system running an image acquisition software application to receive, reformat and transmit image and demographic information. The system receives the image messages from a Computed Radiography or other image source and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data or data entered or configured by an operator through a user interface. The Imageshare Computed Radiography Acquisition stores the data on its local hard disk until the destination acknowledges the successful transmission. Image delivery is also guaranteed when the Imageshare Computed Radiography Acquisition Station loses power and is restarted.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the "Imageshare Computed Radiography Acquisition Station and/or Software." It describes the device's function, intended use, and states its substantial equivalence to a predicate device.
Specifically, the document states:
- No acceptance criteria or device performance table: This information is completely absent from the provided text.
- No study details: There is no mention of any study conducted to assess the device's performance, meeting of acceptance criteria, or any of the other requested details (sample sizes, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details).
- No ground truth type: Because no study is described, there's no mention of the type of ground truth used.
The focus of this 510(k) summary is on establishing substantial equivalence to a previously marketed device based on design, composition, function, intended use, safety, and efficacy, rather than presenting a detailed performance study with acceptance criteria.
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1. 510(k) Summary
遭失彩,一直
510(k) Summary
[As required by 21 CFR 807.92(c)]
Submitter Information 1.0
| 1.1 DeJarnette Research Systems401 Washington Avenue Suite 700Towson MD 21204 | 1.2 Contact: | Eric John Finegan |
|---|---|---|
| Voice: | +1 (410) 583 - 0680 | |
| Fax: | +1 (410) 583 - 0696 | |
| E-mail: | info@dejarnette.com |
8 Sept 1997 1.3 Date Prepared:
Device Identification 2.0
- Imageshare Computed Radiography Acquisition Station and/or Software 2.1 Trade Name:
- Gateway to Digital Imaging Network Common Name: 2.2
- System, Digital Image Communication, accessory Classification Name: 2.3
3.0 Predicate Devices
Imageshare Computed Radiography Acquisition Station and/or Software [DeJarnette Research Systems, Inc.]
4.0 Device Description
-
4.1 Function:
The Imageshare Computed Radiography Acquisition and/or Software is designed to operate on a general purpose computer system running an image acquisition software application to receive, reformat and transmit image and demographic information. The system receives the image messages from a Computed Radiography or other image source and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data or data entered or configured by an operator through a user interface. The Imageshare Computed Radiography Acquisition stores the data on its local hard disk until the destination acknowledges the successful transmission. Image delivery is also guaranteed when the Imageshare Computed Radiography Acquisition Station loses power and is restarted. -
Physical and Performance Characteristics: 4.2
The Imageshare Computed Radiography Acquisition Station and/or Software is designed to run on off-the-shelf, general purpose comment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed. Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.
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5.0 Intended Use:
影视
The Imageshare Computed Radiography Acquisition Station and/or Software is a bi-directional gateway that sends or receives digital images to/from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation's DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0. SPI format or other proprietary data format and transmits the data to one or more userspecified nodes across a standard, general purpose computing network.
Statement of Substantial Equivalence: 6.0
The Imageshare Computed Radiography Acquisition Station and/or Software is substantially equivalent to previously marketed devices (as listed above in Part 3) in design, composition, function, intended use, safety and efficacy. No new issues of safety and effectiveness are raised.
Any differences between the Imageshare Computed Radiography Acquisition Station and the predicate device have no significant influence on safety or efficacy.
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The word "DEPARTMENT" is written vertically along the left side of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eric John Finegan Regulatory Manager DEJARNETTE Research Systems 401 Washington Avenue Suite 700 Towson, MD 21204
Re: K973421
Imageshare Computed Radiography Acquisition Station and/or Software Dated: September 8, 1997 Received: September 10, 1997
Unclassified/Procode: 90 LMD
DEC - 5 1997
POW.SONG, MD., M.SC.
Dear Mr. Finegan:
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, 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 probibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 decemination assumes compliance with the Current Good Manufacturing Practice
rirement, as set forth in the Quality System Regulation (QS) for Modical Devices: General regulation (21 CFR Part 820) and through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply whithe 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 the Act for devices under the Electronic Product 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 aothirestion. 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compilance at (301) 594-4613. Additionally, for questions and advertising of your device, please contact the Office of Compliance at (307) 594-4639. Also, please note the regulation entitled, "Mishanding 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 mumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/edrh/dsmamain.html".
Sincerely yours,
h.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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2. Statement of Indications for Use
Device: Imageshare Computed Radiography Acquisition Station and/or Software
Statement of Indications for Use
[As required by 21 CFR 801.109]
The Imageshare Computed Radiography Acquisition Station and/or
Software is a bi-directional gateway that sends or receives digital images to/from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation's DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(División Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K913467
| Labels | Values |
|---|---|
| Prescription Use | HRS |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use |
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§ 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.