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IQPACS™ 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.

IQPACS is a completely DICOM compliant PACS system, integrating the client and server applications in a clinic/hospital in a PACS network, facilitating the medical images management, offering quick access to radiological images, and making the diagnosing process easier. The IQPACS system consists of a number of applications that can be integrated in a PACS network, considering the client's needs and the specific of every clinical institution.

This document is a 510(k) summary for the IQPACS™ system, a Picture Archiving Communications System (PACS). The information provided focuses on demonstrating substantial equivalence to a predicate device and does not contain details about specific acceptance criteria or performance studies of the IQPACS™ itself.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the provided text does not include this information for the IQPACS™ device. The document primarily establishes:

• Device Name: IQPACS™
• Manufacturer: S.C. INFO WORLD S.R.L.
• Predicate Device: NEOBIT CO., LTD. MEDIPACS™ System (K040486)
• Device Description: A DICOM compliant PACS system for medical image management (capture, storage, communication, processing, display).
• Indications for Use: Receiving digital images and data from various imaging modalities, with specific caveats against lossy compressed mammographic images and requirements for mammographic interpretation monitors.
• Technological Characteristics: Does not contact the patient, does not control life-sustaining devices, and images are interpreted by a physician with "ample opportunity for competent human intervention."
• Conclusion: Substantial equivalence to the predicate device is claimed.

The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or has different technological characteristics but does not raise different questions of safety and effectiveness, and is as safe and effective as the predicate. It does not typically require the submission of new clinical studies with defined acceptance criteria for the new device's performance unless substantial equivalence cannot be otherwise established.

Based on the provided text, the device's "performance" is implicitly deemed acceptable by its substantial equivalence to the predicate device, which would have had its own performance established or demonstrated. However, the document does not detail specific performance metrics, acceptance criteria, or studies for the IQPACS™ itself beyond establishing its safety and effectiveness through comparison to the predicate.

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