Ashvins

K200132 · Medicalcommunications GmbH · LLZ · Feb 18, 2020 · Radiology

Device Facts

• Record ID: K200132
• Device Name: Ashvins
• Applicant: Medicalcommunications GmbH
• Product Code: LLZ · Radiology
• Decision Date: Feb 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Ashvins is a modular software solution and is used for viewing, reporting, processing, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information. Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed. Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.

Device Story

Ashvins is a modular, vendor-neutral PACS software for viewing, reporting, storing, and distributing multimodal medical images (including mammography) and bio-signals. It integrates with hospital/practice information systems (RIS/HIS/EMR) via DICOM and HL7. Input data includes digital images and administrative/patient information. The device performs image processing functions: multiplanar reconstruction (MPR), 3D reconstruction, measurement, zoom, pan, rotate, and windowing. It does not use AI or CAD for diagnosis. Used in medical sites (hospitals/practices) by trained professionals (physicians, radiologists, nurses, technicians) to assist in diagnosis and treatment planning; final clinical decisions remain with the user. It supports web-based distribution and cloud-hosted components. Benefits include centralized image management, efficient data exchange, and standardized visualization tools for clinical workflows.

Clinical Evidence

Bench testing only. Software verification and validation performed to confirm functionality against design requirements and user needs. No clinical data presented.

Technological Characteristics

Modular software PACS; client/server architecture. Supports DICOM, HL7, TCP/IP. Image processing: MPR, 3D reconstruction, measurement, filters (sharpen, CLAHE), windowing/LUT. Connectivity: Networked, cloud-hosted components, web-based access. OS: Windows 2016/19 (Server), Windows 7/10 (Client). Cybersecurity: Access control, data protection for stored/transferred information. Software level of concern: Moderate.

Indications for Use

Indicated for viewing, reporting, processing, storing, and distributing digital multimodal medical images (including mammography) and bio-signals. Intended for use by trained professionals (physicians, radiologists, ophthalmologists, nurses, technicians) in clinical settings. No specific patient population restrictions.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• JiveX 5.0 (K142750)
• FORUM (K122938)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG
ADMINISTRATION

MedicalCommunications GmbH % Mrs. Lena Sattler Consultant Orasi Consulting, LLC. 1655 Forest Drive MEDINA OH 44256

February 18, 2020

### Re: K200132

Trade/Device Name: Ashvins Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, NFJ Dated: January 17, 2020 Received: January 21, 2020

Dear Mrs. Lena Sattler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K200132

Device Name Ashvins

### Indications for Use (Describe)

Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.

Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.

For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.

Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------------------|-----------------------------------------------|
|------------------------------------------------------------------------------------------------|-----------------------------------------------|

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Image /page/3/Picture/0 description: The image shows the logo for ASHVINS Solutions by Medical Communications. The word "ASHVINS" is written in large, bold, dark blue letters. Below it, in smaller letters, it says "Solutions by Medical Communications". There is a light green curved line above the word "ASHVINS".

# 1.510(k) Summary as required by section 807.92(c)

510(k)-number

K200132

Date Prepared February 7, 2020

#### 1.1 510(k) Owner/ Manufacturer

MedicalCommunicatoins GmbH

Max-Jarecki-Strasse 8

69115 Heidelberg, Germany

| Telephone: | [phone] |
|---------------------------------|-------------------------------|
| Facsimile: | [phone] |
| Email: | [e-mail] |
| Establishment Registration No.: | 3003995303 |

#### 1.2 Official Contact Person

### Lena Sattler

| President, Orasi Consulting, LLC. | |
|-----------------------------------|--------------------------|
| 1655 Forest Dr. | |
| Medina, OH 44256 | |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| E-Mail: | [e-mail] |

#### 1.3 Common/Usual Name

Picture Archive And Communication System (PACS)

Image /page/3/Picture/15 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter "C" made up of two curved lines in different shades of green, with a black circle in the center. To the right of the symbol is the text "MedicalCommunications" in a sans-serif font.

MedicalCommunications GmbH Max-Jarecki-Str. 8, D-69115 Heidelberg

[e-mail] www.medicalcommunications.de

MCDOC-1419004256-2672 Version: 0.1 Template Version: 1.0

510(k) Summary_K200132_cleanversion

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Image /page/4/Picture/0 description: The image shows the logo for ASHVINS Solutions by Medical Communications. The word "ASHVINS" is in large, bold, blue letters. Below that, in smaller blue letters, it says "Solutions by Medical Communications". There is a green swoosh above the word "ASHVINS".

#### Proprietary or Trade Names 1.4

Proprietary Name:

- . Ashvins
Trade Names:

- Ashvins Diagnostic Workstation ●
- Ashvins Web Extreme .
- Ashvins Image & Web Management (Data Management) .
- HEYEX 2 / HEYEX PACS (Product Family: HEIDELBERG EYE EXPLORER) .

#### Classification Information 1.5

| Classification Name: | System, Image Processing, Radiological [LLZ],<br>System, Image Management, Ophthalmic [NFJ] |
|----------------------|---------------------------------------------------------------------------------------------|
| Medical Specialty: | Radiology |
| Device Class: | II |
| Product Code: | LLZ, NFJ |

#### Product Code: Classification / CFR Title 1.6

| LLZ, NFJ: | Class II § 21 CFR 892.2050 |
|------------------|---------------------------------------------|
| Regulation Name: | Picture Archiving and Communications System |

#### 1.7 Predicate Devices

### Table 2: Primary Predicate Device, Secondary Predicate Device

| Primary Predicate Device: JiveX 5.0 | Secondary Predicate Device: FORUM |
|-------------------------------------|-----------------------------------|
| Radiology | Ophthalmology |
| VISUS Health IT | Carl Zeiss Meditec AG |
| Device Class: II | Device Class: II |
| Product Code: LLZ | Product Code: NFJ |
| 21 CFR 892.2050 | 21 CFR 892.2050 |
| K142750 | K122938 |

MedicalCommunications GmbH Max-Jarecki-Str. 8, D-69115 Heidelberg

[e-mail] www.medicalcommunications.de

Image /page/4/Picture/19 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter C made up of two curved lines, one in dark blue and the other in light green. Inside the C is a black circle. To the right of the logo is the text "MEDICALCOMMUNICATIONS" in a sans-serif font.

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Image /page/5/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The word "ASHVINS" is in large, bold, blue letters. Below that, in smaller blue letters, is the phrase "Solutions by MedicalCommunications."

#### General Device Description 1.8

### Device Description

Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammoqraphic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.

Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.

Ashvins does not utilize artificial intelligence or computer-aided diagnosis to identify abnormalities in medical images or to assist in diagnosis.

For primary image diagnosis in Mammography only uncompressed images and only preprocessed DICOM *For Presentation" images must be used. Existing regulatory or legal require-ments regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.

Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiolo-gists, ophthalmologists, nurses, medical technicians, and assistants.

Ashvins integrates systems including, but not limited to, devices and information systems for medical practices and hospitals (such as radiology and/or ophthalmology information systems, etc.) in accord-ance with international standards. Ashvins also provides manufacturer-specific interfaces for other sys-tems/devices.

Ashvins offers the possibility of capturing and digitizing documents such as PDFs, single images, image sequences and film sequences, as well as converting and archiving them in DICOM format. As such, Ash-vins serves as a manufacturer-independent image management system and archive, a so-called "Vendor Neutral Archive."

Ashvins also provides functions for the collection, processing, and transfer of medical and administrative data in hospitals or medical practices, including billing functions.

Ashvins allows the visualization and statistical evaluation of meta data provided by the devices.

Ashvins is used at a physician's workplace to assist the physician with diagnosis and treatment planning, but the product itself does not generate an automated diagnosis, findings, or a treatment plan. The final decision regarding the diagnosis always remains with the physician or the medical staff within their own decision-making area.

Ashvins is offered in different variants with different ranges of functions for different application areas depending on the configuration (for further information see document "General Description of Product Vari-ants").

Image /page/5/Picture/14 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter "C" formed by two curved lines in different shades of blue and green, with a black dot in the center. To the right of the symbol, the words "MedicalCommunications" are written in a simple, sans-serif font.

MedicalCommunications GmbH Max-Jarecki-Str. 8. D-69115 Heidelberg CDOC-1419004256-2672

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Image /page/6/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The logo features the company name in a bold, sans-serif font, with the word "ASHVINS" in a larger font size than "Solutions by MedicalCommunications". A teal swoosh appears above the company name. The overall design is clean and professional.

- Ashvins variant Ashvins Diagnostic Workstation ●
- . Ashvins variant Ashvins Web Extreme
- Ashvins variant Ashvins Image & Web Management (Data Management)
- . Ashvins variant HEYEX 2 / HEYEX PACS

### Intended patient groups

There are no specific requirements related to gender, age, or other biological and anatomical characteris-tics of patients for the use of Ashvins.

Ashvins is applicable for all patients. The imaging data is delivered by the imaging devices on which the patients are examined.

### Intended usage environment/use environment

Ashvins is used at a medical site such as a medical practice or a hospital, and it has components hosted in the Cloud.

Generally, the diagnostic workstations are used in darkened rooms. These relevant directives and stand-ards must be observed. For other client stations of Ashvins there are no restrictions regarding the place of use.

### Service and maintenance

Maintenance and configuration of Ashvins may only be carried out by professionals after appropriate train-ing. It is recommended that a maintenance contract be attained from the manufacturer.

#### 1.9 Indications for Use

### Intended Use

Ashvins is a modular software solution and is used for viewing, reporting, processing, storing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.

Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.

Image /page/6/Picture/17 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter "C" formed by two curved lines in different shades of green and blue, with a black circle inside the "C". To the right of the symbol is the text "MedicalCommunications" in a simple, sans-serif font. The text is in a dark color, likely black or a dark shade of gray, providing a clear contrast against the white background.

MedicalCommunications GmbH Max-Jarecki-Str. 8. D-69115 Heidelberg

[e-mail]

www.medicalcommunications.de

CDOC-1419004256-2672

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Image /page/7/Picture/0 description: The image shows the logo for ASHVINS Solutions by Medical Communications. The logo features the company name in a bold, sans-serif font, with the word "ASHVINS" in a larger font size than "Solutions by Medical Communications". A teal swoosh appears above the company name. The overall design is clean and professional.

For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.

Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.

## 1.10 Substantial Equivalence

The Substantial Equivalence table below illustrate the comparison of Ashvins to the predicate devices.

### Table 3: Subjected device Ashvins compared to the Predicate devices K142750 and K12293

| Feature | Subject | Primary Predicate Device<br>(K142750) | Secondary Predicate<br>Device<br>(K122938) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ashvins | JiveX 5.0 | FORUM |
| Submitter/Manufac-<br>turer | MedicalCommunications<br>GmbH | VISUS Health IT | Carl Zeiss Meditec AG |
| Indications for Use | Ashvins is a modular soft-<br>ware solution and is used<br>for viewing, reporting, pro-<br>cessing, storing, printing,<br>and archiving, as well as for<br>the exchange and distribu-<br>tion or web-based distribu-<br>tion of digital, multimodal<br>medical images, including<br>mammographic images and<br>bio-signals, as well as find-<br>ings and demographic infor-<br>mation. Ashvins also col-<br>lects, manages, and distrib-<br>utes patient-related and de-<br>vice-related information. | JiveX is a software only<br>Picture Archiving and<br>Communication System<br>intended to display, pro-<br>cess, read, report, com-<br>municate, distribute,<br>store, and archive medi-<br>cal data which is available<br>as DICOM or HL7 data, in-<br>cluding mammographic<br>images, and bio signals.<br>JiveX also converts case<br>related non-image docu-<br>ments, archives them as<br>DICOM data and serves | FORUM is a software<br>system intended for use<br>in storage, manage-<br>ment, processing, and<br>display of patient, diag-<br>nostic, video and image<br>data and measurement<br>from computerized di-<br>agnos-tic instruments<br>or documentation sys-<br>tems through networks.<br>It is intended to work<br>with other FO-RUM ap-<br>plications. |
| Feature | Subject | Primary Predicate Device<br>(K142750) | Secondary Predicate<br>Device<br>(K122938) |
| | Ashvins | JiveX 5.0 | FORUM |
| | Ashvins offers advanced im-<br>age processing functions<br>such as multiplanar recon-<br>struction, 3D reconstruc-<br>tion and measurement<br>functions.<br><br>For primary image diagnosis<br>in Mammography only un-<br>compressed or non-lossy<br>compressed images and<br>only preprocessed DICOM<br>"For Presentation" images<br>must be used. Existing reg-<br>ulatory or legal require-<br>ments regarding hardware,<br>such as diagnostic moni-<br>tors, that are applicable for<br>diagnosing in respective im-<br>aging specialties must be<br>observed.<br><br>Ashvins is designed to be<br>used by trained profession-<br>als, including but not limited<br>to physicians, radiolo-gists,<br>ophthalmologists, nurses,<br>medical technicians, and as-<br>sistants. | as a vendor neutral ar-<br>chive.<br><br>It supports the physician<br>in diagnosis.<br><br>For primary image diag-<br>nosis in Mammography<br>only uncompressed or<br>non-lossy compressed<br>images must be used.<br>Also monitors (displays)<br>and printers which re-<br>ceived FDA clearance for<br>Mammography must be<br>used.<br><br>Typical users of this sys-<br>tem are trained profes-<br>sionals, including but not<br>limited to physicians, ra-<br>diolo-gists, nurses, medi-<br>cal technicians, and assis-<br>tants.<br><br>Note: Web-based image<br>distribution and mobile<br>device display are not in-<br>tended for diagnostic pur-<br>pos-es. | FORUM is intended for<br>use in review of patient,<br>diagnostic and image<br>data and measurement<br>by trained healthcare<br>professionals. |
| Regulation description | Picture archiving and communication system | Picture archiving and communication system | Picture archiving and communication system |
| Feature | Subject | Primary Predicate Device<br>(K142750) | Secondary Predicate<br>Device<br>(K122938) |
| | Ashvins | JiveX 5.0 | FORUM |
| Prescription/over-<br>the-counter use | Prescription | Prescription | Prescription |
| Classification | Device Class: II | Device Class: II | Device Class: II |
| | Product<br>Code:<br>LLZ, NFJ | Product<br>Code:<br>LLZ | Product<br>Code:<br>NFJ |
| | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Target Population | Images/System is not pa-<br>tient population specific | Images/System is not pa-<br>tient population specific | Images/System is not<br>patient population spe-<br>cific |
| Design/ Architecture | Client/server | Client/server | Client/server |
| Operating systems | Server: Win 2016/19<br>Client: Win 7/10 | Server: Win<br>7/8.1/10/<br>Srv. 2008/2012<br>Client: Win. 7/8.1/10 | Windows XP, Windows<br>Server 2003 (Server<br>only) Windows 7, Win-<br>dow Server 2008 R2,<br>Mac Lion (Client only) |
| Hardware<br>require-<br>ments | Windows based, manufac-<br>turer | Windows based, manu-<br>facturer | Windows based, manu-<br>facturer |
| | independent server, work-<br>stations and | independent<br>server,<br>workstations and | independent<br>server,<br>workstations and |
| | client hardware, iPAD | client hardware, iPAD | client hardware |
| Image communica-<br>tion | TCP/IP, DICOM, proprietary<br>internal image transfer pro-<br>tocol | TCP/IP, DICOM, proprie-<br>tary internal image trans-<br>fer protocol | TCP/IP, DICOM, propri-<br>etary internal image<br>transfer protocol |
| Accepted<br>Image<br>Formats | DICOM<br>data + data ac-<br>cepted as non DICOM and<br>converted to DICOM<br>for | DICOM data + data ac-<br>cepted as non DICOM and<br>converted to DICOM for | DICOM |
| Feature | Subject | Primary Predicate Device<br>(K142750) | Secondary Predicate Device<br>(K122938) |
| | Ashvins | JiveX 5.0 | FORUM |
| | storage: PDF, standard and other proprietary formats | storage: PDF, standard and proprietary ECG formats | |
| Supported storage solutions | Local storage on HDD/RAID/DVD, Network: NAS, SAN, long term storage solutions | Local storage on HDD/RAID/DVD, Network: NAS, SAN, long term storage solutions | Local storage on HDD/RAID/DVD, Network: NAS, SAN, long term storage solutions |
| Image data compression | JPEG 2000 lossless& lossy, ZIP, JPEG lossless & lossy, MPEG-1, MPEG-2, MPEG-4 | JPEG 2000 lossless & lossy, ZIP, JPEG lossy for web clients Display as received: JPEG lossless & lossy, RLE lossless, MPEG-2 | JPEG 2000 lossless, JPEG lossless, RLE lossless, MPEG-2, MPEG-4 |
| Web based acces | Yes, Desktop & mobile devices (not intended for reading) | Yes, Desktop & mobile devices (not intended for reading) | No |
| Virtualization | Yes, VMware. Desktop and web clients can be distributed via Citrix | Yes | Yes |
| Cebtralized user administration | Yes | Yes | Yes |
| RIS/HIS/EMR integration | Yes, Via standards HL7 and DICOM, aligned to IHE Framework | Yes, Image Call Up from RIS, Patient Information Reconciliation, Instance Availability. Receive documents via HL7 MDM. Supported Standards: HL7, IHE | Yes, Via standards HL7 and DICOM |
| Feature | Subject | Primary Predicate Device<br>(K142750) | Secondary Predicate<br>Device<br>(K122938) |
| | Ashvins | JiveX 5.0…