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rChive™ PACS is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

rChive™ PACS is a Picture Archival and Communication System (PACS), which facilitates image viewing at diagnostic, reporting, consultation and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short or long-term storage devices. rChive™ PACS allows communication using local or wide-area networks, public communications services, systems that include modality interfaces and gateways to healthcare facility and departmental information systems.

This 510(k) summary (K063253) for the rChive™ PACS device does not contain the information requested regarding acceptance criteria or a dedicated study proving the device meets specific performance criteria.

The document is a standard 510(k) submission focused on demonstrating substantial equivalence to a predicate device (MEDIPACS, K040486), rather than on presenting performance data from a specific clinical or technical study.

Here's why the requested information is absent based on the provided text:

• No Acceptance Criteria or Reported Device Performance Table: The document doesn't define any specific quantitative acceptance criteria (e.g., sensitivity, specificity, image quality metrics) or report actual performance data against such criteria.
• No Study Described: There is no mention of an independent study, clinical trial, or technical evaluation specifically designed to measure the rChive™ PACS's performance against acceptance criteria. The submission primarily relies on demonstrating that its technological characteristics, indications for use, and design architecture are substantially equivalent to the predicate device.
• No Information on Sample Size, Data Provenance, Experts, Ground Truth, MRMC, or Standalone Performance: Since no specific performance study is detailed, these related data points (sample size, data provenance, number/qualification of experts, adjudication, MRMC, standalone performance, training set details) are also not present in the document.

Summary from the provided text:

The submission confirms that the rChive™ PACS is a Picture Archival and Communication System (PACS) intended for medical image and data distribution, similar to the predicate device MEDIPACS (K040486). It states that the two devices are "substantially equivalent in the areas of design architecture, general function, application, and intended use," and that "Any differences between the two devices will not affect safety or efficacy." The device does not contact the patient, nor does it control any life-sustaining devices, and a physician interprets the displayed images and information.

Conclusion based on the provided text:

The provided 510(k) summary for K063253 focuses solely on demonstrating substantial equivalence to a predicate device and does not include the details of a study with acceptance criteria and device performance evaluation that you requested. Such detailed performance studies are often not explicitly required for 510(k) submissions where substantial equivalence can be demonstrated through other means (e.g., technical comparisons, adherence to standards, and risk analysis).

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