MEDSTATION

• K Number: K973090
• Device Name: MEDSTATION
• Manufacturer: PROGRAM S.R.L.
• Date Cleared: 1997-10-28 ( 71 days)
• Product Code: LMD
• Regulation Number: 892.2020
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

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 Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification acceptance letter for a Picture Archiving and Communications Systems (PACS) device, K973090, dated October 28, 1997. It describes the device's indications for use and states that it has been found substantially equivalent to predicate devices. However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document only states:

• Device Name: MedStation® PACS
• 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.
• Regulatory Class: Unclassified
• Product Code: 90 LMD

Therefore, I cannot provide the requested information in a table or answer the specific questions about studies, sample sizes, ground truth, or expert qualifications, as this data is not present in the provided text. This type of information would typically be found in a separate 510(k) summary or a detailed clinical/technical report, not in the acceptance letter itself.

Regulation Number and Section

§ 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.