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"Harmony", is a suite of products comprised out of scalable levels of modular software programs, designed to perform the necessary functions required for the import, export, storage, archiving, review, analysis, reporting and database management of multimodality digital medical images.

"Harmony" software will run on Intel based commercial hardware under Microsoft Windows based operating systems.

Philips "Harmony" software is a suite of DICOM products containing scalable levels of modular software programs, designed to perform the necessary functions required for the import/export/storage/archiving/review/analysis/reporting and database management of digital cardiovascular images within the cardiology domain.

It allows multiple users quick access to, and exchange of specific and/or multiple cardiology exams.

Because of the open architecture, the "Harmony" software will run on Intel based commercial hardware under Microsoft Windows based operating systems. Together with the modular design it allows the user to tailor the image import, archive and communications solution to his particular budgetary and performance needs and the number of modalities and reporting and/or viewing sites he decides to connect. PHILIPS will guarantee stability and (different levels of) performance when used with specific hardware configurations and network infrastructure.

The following packages are marketed:

• Standalone Workstation .
• Integrated Workstation network solution ●
• Base, Advanced and Premium network solutions .

These software packages will be delivered on a set of CD-ROMs, which contain the installation application, the application software, the service software and an electronic copy of the instructions for use.

The provided text is a 510(k) summary for the Philips "Harmony" Release 1 software. It details the device's general information, system description, intended use, and comparison to predicate devices for substantial equivalence. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on:

• General Information: Company name, address, contact, device name, classification, and predicate devices.
• System Description: Philips Harmony software is a suite of DICOM products for managing digital cardiovascular images (import/export/storage/archiving/review/analysis/reporting and database management).
• Intended Use: Integrated multimodality image and information system for managing digital medical images.
• Substantial Equivalence: Comparison with Philips Inturis Suite and Philips EnConcert based on technological characteristics (Operating System, Memory Requirement, Image Source, Connectivity, Display Rate, Multiple Windows, Image Display Controls, Annotation, Image Export, Network Access).
• Safety Information: States that no new hazards are introduced and the device is of minor level of concern.
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence to predicate devices.
• Indications for Use: Reiterates the device's functions.

Since the document does not present specific acceptance criteria or an associated study, I cannot fill in the requested table and details. The 510(k) process for devices like this typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with acceptance criteria in the same way a de novo or PMA submission might. The "performance" described is largely about features and functionalities aligning with existing cleared devices.

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