(71 days)
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No
The summary describes a standard PACS system for image management and does not mention any AI/ML capabilities or related performance metrics.
No
The device is described as a system for acquiring, storing, displaying, and printing medical images from diagnostic devices, not for treating a disease or condition.
No
The device is described as a system to acquire, store, display and print medical images from diagnostic devices, not a diagnostic device itself.
No
The description explicitly states the system is designed to acquire, store, display, and print medical images. While it handles data, the functions of acquiring, storing, displaying, and printing typically involve hardware components (servers, workstations, printers, etc.) in addition to software. The summary does not provide information to suggest it is only the software component of such a system.
Based on the provided information, the MedStation® PACS device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MedStation® PACS Function: The intended use of MedStation® PACS is to acquire, store, display, and print medical images from various imaging modalities (CT, MRI, CR, DR, Ultrasound, X-ray Films). These are in vivo imaging techniques, meaning they capture images of the inside of the body without taking samples.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples or any diagnostic tests performed on such samples.
Therefore, MedStation® PACS falls under the category of medical imaging systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
MedStation® PACS is a system designed to acquire, store, display and print medical images from the following diagnostic devices: Computed Tomography (CT), Magnetic Resonance Imagers (MRI), Computed Radiography (CR), Direct Radiography (DR), Ultrasound and X-ray Films.
Product codes
90 LMD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance Imagers (MRI), Computed Radiography (CR), Direct Radiography (DR), Ultrasound and X-ray Films.
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Image /page/0/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 an abstract human figure or a caduceus, with three wavy lines representing the body and a wing-like shape above.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/0/Picture/4 description: The image shows a date, "OCT 28 1997". The month is October, the day is the 28th, and the year is 1997. The text is in a bold, sans-serif font. The text is black against a white background.
Diana Upton c/o Diana Upton 719 Catapla Avenue Teaneck, NJ 07666
K973090 Re:
Picture Archiving and Communications Systems (Pacs) Dated: August 15, 1997 Received: August 18, 1997 Regulatory class: Unclassified Procode: 90 LMD
Dear Ms. Upton:
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 prohibitions 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 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 OS 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 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,
William 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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•
1
K973090
510(k) Number (if known):
PACS Software
Device Name:
Indications for Use:
MedStation® PACS is a system designed to acquire, store, display and print medical images from the following diagnostic devices: Computed Tomography (CT), Magnetic Resonance _ _ _ Imagers (MRI), Computed Radiography (CR), Direct Radiography (DR), Ultrasound and X-ray Films.
(PLEASE DO KOT WRITE DELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K973090 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | -------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
4.3