MEDSTATION

K973090 · Program S.R.L. · LMD · Oct 28, 1997 · Radiology

Device Facts

• Record ID: K973090
• Device Name: MEDSTATION
• Applicant: Program S.R.L.
• Product Code: LMD · Radiology
• Decision Date: Oct 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended 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.

Device Story

MedStation® PACS functions as a Picture Archiving and Communication System; acquires, stores, displays, and prints medical images from CT, MRI, CR, DR, Ultrasound, and X-ray sources. System enables clinicians to view and manage diagnostic images for clinical decision-making. Used in clinical environments; operated by healthcare professionals. Device facilitates image archival and retrieval, supporting diagnostic workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PACS software system for image acquisition, storage, display, and printing. Supports DICOM-compatible modalities including CT, MRI, CR, DR, Ultrasound, and X-ray films.

Indications for Use

Indicated for the acquisition, storage, display, and printing of medical images from CT, MRI, CR, DR, Ultrasound, and X-ray modalities for clinical diagnostic purposes.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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## 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.

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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 | <div>✓</div> | OR | Over-The-Counter Use |
|------------------|--------------|----|----------------------|
|------------------|--------------|----|----------------------|

(Optional Format 1-2-96)

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