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dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data.

dicomPACS® DX-R can control X-ray generators. dicomPACS®DX-R is not approved for the acquisition of mammographic image data.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Functions to be carried out using dicomPACS® and dicomPACS® DX-R are, for example, but not limited to adjustment of window leveling, rotation, zoom, and measurements.

dicomPACS® and dicomPACS®DX-R are meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data.

dicomPACS® DX-R can control X-ray generators.

The software comes in two varieties - as dicomPACS® 5.2. and as dicomPACS® DX-R 1.6. While dicomPACS® DX-R 1.6 provides some functionality like generator control, CR/DR acquisition and raw data processing, dicomPACS® does not have these functions.

The provided text is a 510(k) summary for the dicomPACS® 5.2 and dicomPACS® DX-R 1.6 devices. It describes modifications made to the device and asserts substantial equivalence to a predicate device, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document primarily focuses on:

• Administrative information about the submission.
• Indications for Use for the updated devices.
• A functional comparison table highlighting new features in the updated versions.
• Identification of "significant changes" to the device (Multiplanar Reconstruction, CR/DR acquisition, and Raw data processing).
• A "Substantial Equivalence Conclusion" stating that the modifications do not alter the Indications for Use, fundamental scientific technology, or introduce new safety/effectiveness questions.
• The FDA's letter of substantial equivalence.

Therefore, I cannot provide the requested information from the provided text. The document is an application for market clearance based on substantial equivalence, not a performance study report.

No information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either training or test sets is present in the provided text.

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dicomPACS® is a software system for the administration, archiving, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® also provides services for administering the data.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Functions to be carried out using dicomPACS® are, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements.

dicomPACS® is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

dicomPACS® is a Picture Archiving and Communications System (PACS), as are the two Predicate Devices HIPAX and eFilm. All of them have been developed to acquire, store, communicate, display and process medical images, for example X-ray, CR, CT, MRI, and ultrasound images etc. They offer features (e.g. window levelling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions.

dicomPACS® has a modular system architecture. It consists of the basic application dicomPACS-Viewer for image viewing and processing, the dicomControlCenter as application for image storage and communication and a number of other modules for database management, image acquisition, printing etc.

dicomPACS® conforms to the DICOM (Digital Imaging and Communications in Medicine) standard.

dicomPACS® is an autonomous software and involves no hardware.

The provided text is a 510(k) summary for the dicomPACS® device, a Picture Archiving and Communications System (PACS). While it describes the device's intended use and comparison to predicate devices, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or detailed performance metrics like sensitivity, specificity, or AUC.

The document states: "dicomPACS® has been tested according to the specifications documented in this notification (Section 14 g). It conforms to the DICOM standard as laid out in the included DICOM Conformance Statement." However, "Section 14 g" and the DICOM Conformance Statement are not provided in this extract, nor are any performance results from such testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The information primarily focuses on:

• Device identification: Trade name, common name, applicant details, regulation number, classification.
• Device description: Functionality (acquire, store, communicate, display, process medical images), modular architecture, DICOM conformance.
• Predicate devices: HIPAX (K052411) and eFilm Workstation (K020995) are identified as comparable devices.
• Intended use: Acquisition, storage, communication, and viewing of medical images from various modalities, with tools for viewing (zoom, filters, measurements) and exchange. It also mentions integration with RIS/KIS.
• Technological characteristics: Software-only, runs on specific MS Windows operating systems, does not control life-sustaining devices, and requires interpretation by qualified specialists.
• Conclusion: Stating substantial equivalence to predicate devices.
• FDA Communication: A letter from the FDA stating the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Further detailing the device's use for administration, archiving, improvement, and compression of medical image data for diagnosis, emphasizing requirements for mammographic images.

In summary, the provided text does not contain the specific performance study information requested.

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