IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM

• K Number: K963395
• Device Name: IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
• Manufacturer: SECTRA-IMTEC AB
• Date Cleared: 1996-10-25 ( 58 days)
• Product Code: LMB
• Regulation Number: 892.2010
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K922164

Intended Use

The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images.

Device Description

The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images.

AI/ML Overview

This document is a 510(k) summary for the SECTRA ImageServer 2000 Picture Archiving System, dated August 16, 1996. It outlines the safety and effectiveness information for regulatory submission.

Based on the provided text, the document does not contain the detailed information required to answer the request about acceptance criteria and a study proving device performance. The summary focuses on regulatory compliance and general safety statements rather than specific performance metrics or clinical study results.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: The document states that the system will "digitally store images for archival together with information about the images." It doesn't provide any quantitative performance metrics (e.g., accuracy, speed, image quality retention, error rates, clinical outcomes) that would serve as acceptance criteria or reported performance data. Therefore, a table of acceptance criteria and reported device performance cannot be generated.
• Study Details: There is no mention of a specific study, clinical trial, or performance evaluation that was conducted to demonstrate the device's efficacy or safety in terms of clinical outcomes or diagnostic accuracy.
  • Sample size and data provenance: Not mentioned.
  • Number of experts and qualifications: Not mentioned.
  • Adjudication method: Not mentioned.
  • MRMC comparative effectiveness study: Not mentioned.
  • Standalone (algorithm only) performance: Not applicable as this is an archiving system, not an AI diagnostic algorithm.
  • Type of ground truth: Not mentioned.
  • Sample size for training set: Not applicable as this is an archiving system, not an AI diagnostic algorithm.
  • How ground truth for training set was established: Not applicable.

The document primarily states:

• The ImageServer System will be used for digitally storing images and associated information.
• Typical users are trained medical professionals.
• It complies with Federal Performance Standards (21 CFR, part 1000).
• It was manufactured in accordance with voluntary standards.
• The User's Guide contains information for safe and effective use.
• A hazard analysis was performed.

This information is insufficient to address the questions posed, which are typically relevant to diagnostic or therapeutic devices undergoing performance validation. The SECTRA ImageServer 2000, as described, is a Picture Archiving System (PACS), and its "performance" is more related to its functionality in storing, retrieving, and displaying images, rather than diagnostic accuracy.

Regulation Number and Section

§ 892.2010 Medical image storage device.

(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(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.