RADIN, MODEL V 3.0

K043483 · Sohard AG · LLZ · Jan 28, 2005 · Radiology

Device Facts

• Record ID: K043483
• Device Name: RADIN, MODEL V 3.0
• Applicant: Sohard AG
• Product Code: LLZ · Radiology
• Decision Date: Jan 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

RADIN can be used whenever digital images and associated data acquired or generated by different third party modalities have to be accepted, displayed, transmitted, stored, distributed, processed and archived in order to be available for professional health care personnel. RADIN is not intended to assist the healthcare personnel in diagnosis. RADIN can be used together with appropriate and proper installed computer platforms according to the recommendations made in the labeling. 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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users are trained healthcare professionals including but not limited to physicians, licenced practitioners, nurses.

Device Story

RADIN 3.0 is a PACS software system for distribution/archiving of medical images/reports. Inputs: DICOM-formatted images from hospital modalities (CR, CT, MR, NM, etc.) via network. Operation: Server-based architecture (RADIN.online) manages data; web-based communication (RADIN.web) enables access; optional long-term archiving (RADIN.archive) supports hard disks/jukeboxes. Clients (Classic, Expert, Expert Dual Monitor) run on standard PCs via web browser. Features: image viewing, manipulation (zoom, pan, window leveling, edge enhancement, grayscale inversion), and basic measurements (distance, angulation, density). Output: visual display of images/reports for clinical review. Usage: healthcare environments (hospitals, clinics, physician offices/homes). Decision-making: supports physicians/staff in diagnosis; final diagnostic responsibility remains with the clinician. Benefits: facilitates remote access to medical imaging data and workflow integration with HIS/RIS/CIS.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included hazard analysis, verification/validation testing of software modules, and integration testing to ensure compliance with specifications and risk management requirements.

Technological Characteristics

Stand-alone software package; runs on standard PC hardware (Windows 2000 Server/XP). Connectivity: TCP/IP, DICOM 3.0 compliant. Data security: SSL encryption, VPN. Image processing: JPEG (lossless/lossy), Wavelet compression. Architecture: Server-client (web-based). Sterilization: N/A (software).

Indications for Use

Indicated for use by trained healthcare professionals (physicians, licensed practitioners, nurses) to accept, display, transmit, store, distribute, process, and archive digital medical images and associated data from third-party modalities. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images; mammographic images require FDA-approved monitors (min 5 Mpixel).

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

• Thinking Systems ThinkingNet (K010271)

Submission Summary (Full Text)

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. A SOHARD Premarket Submission RADIN

SOHARD AG Wuerzburger Str. 197 90766 Fuerth Germany

Image /page/0/Picture/3 description: The image shows the date 11/19/2004 at the top. Below the date is a line, and below the line is the text 'K04 3483'. The text appears to be handwritten in a dark ink. The background is white.

E. Administrative Information

JAN 2 8 2005

## E.1 510(k) Summary of Safety and Effectiveness

#### E.1.1 Company Identification

SOHARD AG Wuerzburger Str. 197 90766 Fuerth Germany 011-49911-97341-0 Tel.: [phone] Fax.:

### E.1.2 Official Correspondent

Ralph Loos, RA/QM Wuerzburger Str. 197 90766 Fuerth Germany 011-49911-97341-553 Tei.: 011-49911-97341-510 Fax .:

#### E.1.3 Date of Submission

11/19/2004

#### E.1.4 Device Name

| Trade name: | RADIN |
|-------------------------|-----------------------------------------------------|
| Release Version: | 3.0 |
| Common name: | RADIN |
| Classification Name: | Picture Archiving and Communications System |
| Reference: | per 21 CFR 892.2050 |
| Class: | II |
| Review Panel: | Radiology |
| Product Classification: | 90 LLZ, Picture Archiving and Communications System |

Guidance for the submission of premarket notifications for Guidance document: medical image management systems (issued on july 27, 2000)

### E.1.5 Substantial Equivalence

The RADIN Software is substantially equivalent, in the opinion of SOHARD AG, to Thinking Systems ThinkingNet (K010271, Class II).

#### E.1.6 Device Description

RADIN 3.0 is a system to distribute medical images and reports within and outside of health care environments. It is available as a stand-alone software package.

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RADIN consists of the following set of software modules:

- t RADIN.online is the main component, its scalable server architecture provides high availability of medical images
- . RADIN.web provides standardized internet technology for web-based image communication
- RADIN.archive enhances RADIN.online with long term archiving on media (e.g. harddisk, jukebox)

RADIN offers three types of clients:

- RADIN.Classic Client provides the basic viewing and workflow features, e.g. . support of CR, CT, MR and NM modalities, support of greyscale, color and multiframe images.
- . RADIN.Expert Client additionally offers gamma adjustment, display of scoutlines and image export.
- . RADIN.Expert dual monitor Client supports dual monitor operation

RADIN requires standard PC-Hardware, recommendations are made within the labeling.

#### E.1.7 Intended Use

RADIN 3.0 is a system to distribute medical images and reports within and outside of health care environments.

The RADIN Server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities and workstations. The modalities that are supported by RADIN are listed in the DICOM Conformance Statement [1].

For data transfer to clients you have to activate strong SSL data encryption to make the transfer secure.

Data that are stored on the RADIN server can be accessed simultaneously by many viewing stations within a healthcare enterprise or from elsewhere outside. The image data transfer is done in DICOM format via the Intranet or the Internet, for example to stations located in a doctor's office, throughout hospitals or a physician's home.

Integration with other hospital information systems (HIS, RIS, CIS) is possible via a special OEM interface.

Images can be viewed directly within a web browser (Internet Explorer). The system offers simple functions for image manipulation and measurements. Reports can be viewed together with the images on one page.

RADIN can support physicians and/or their medical staff with the diagnosis. In that case the user is responsible for all suitable hardware being used in proper working conditions. The final decision regarding diagnoses, however, lies with the doctors and/or their medical staff in their very own responsibility.

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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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA (concerning only the USA).

RADIN offers an archiving option for long-term storage of image data. Only the data consistency on archive media is guaranteed, the system provider has to take own appropriate means (e.g. redundancy) for safety against data loss caused by media destruction. Without the archiving option, the RADIN System features no components for long-term data archiving. Additional archiving on film or in digital form is therefore necessary.

RADIN provides three types of clients:

RADIN.Classic for basic functionality RADIN.Expert for full functionality RADIN.Expert Dual Monitor with RADIN.Expert functionality and support of two monitors

All text and messages displayed in the image viewer can be viewed in either: German English French Spanish Italian Portuguese

The Online Help for the image viewer is available in German and English. The text of the administration pages and the Online Help of the administration pages are available in English only.

To guarantee flawless operation of the RADIN system, no additional 30 party software may be installed on RADIN server. Furthermore, no part of the RADIN product may be manipulated in any way.

If the system is configured to use only patient ID for matching of patient data, the system provider has to make sure that each patient ID is unique for the whole system. Therefore, all interfaces that can deliver images into the system have to be considered especially interfaces to external institutions.

### E.1.8 Software Development

SOHARD AG certifies, that the RADIN software is designed, developed, tested and validated according to written procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance.

All employees receive the appropriate quality system training.

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The SOHARD Quality System is in compliance with the following voluntary and mandatory standards and regulations:

| Standard/Requlation | Title |
|---------------------|------------------------------------------------------------------------------------------------|
| 21 CFR 820 | Quality Systems Regulation |
| ISO 9001:2000 | Quality Management Systems - Requirements |
| ISO 13485:2000 | Quality Systems - Medical Devices - Particular requirements<br>for the application of ISO 9001 |
| 93/42/EEC | Medical Device Directive |
| (IEC) 60601-1-4 | International Electrotechnical Commission |

### E.1.9 Substantial Equivalence Comparison Chart

RADIN has equivalent Intended use and technological characteristics as the predicate device and therefore raises no new safety or effectiveness issues.

| Product | RADIN | Thinking Net |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| General | | |
| Networking | TCP/IP | TCP/IP |
| Image Acquisition/Communication | DICOM Compliant | DICOM Compliant |
| Image file formats | DICOM 3.0 | DICOM 3.0<br>Interfile 3.3 |
| Imaging modalities | Multi Modality | Multi Modality |
| Platform | PC | PC |
| Operating System | Windows | Windows |
| Standard Microsoft Technology | Yes | Yes |
| DICOM 3.0 Compliant | Yes | Yes |
| Patient Demographics | Yes | Yes |
| DICOM Storage SCP | Yes | Yes |
| DICOM Storage SCU | Yes | Yes |
| DICOM Query/Retrieve SCU/SCP | Yes | Yes |
| HIPAA compliant | Yes | Yes |
| Scalability | RADIN.Online<br>1 to several 500 users | yes |
| Data Compression | | |
| Original Format | Yes | Yes |
| JPEG Lossless | Yes | Yes |
| JPEG Lossy | Yes (5-100%) | Yes |
| Wavelet | Yes (5-100%) | No |
| Storage Space Management | | |
| Intelligent storage management | Yes | Yes |
| Product | RADIN | Thinking Net |
| DICOM Network | | |
| DICOM Conformance | DICOM 3.0 | DICOM 3.0 |
| Hardware and Software<br>Requirements | | |
| Hardware | PC Pentium III, min<br>500MHz<br>512 MB RAM<br>20 GB Harddisk | OTS Hardware ac-<br>cording to specified<br>minimum hardware<br>requirements |
| Software | Windows 2000 Server<br>Internet Explorer 6 | Windows 2000 Server |
| | RADIN.Web | |
| Security Features | | |
| User authentication | yes | yes |
| Secure data transmission | SSL encryption<br>(optional:<br>encryption)<br>VPN | VPN encryption |
| User Management | | |
| User Account | Yes | Yes |
| User groups | Yes | Yes |
| User Levels | Yes | Yes |
| Workflow Features | | |
| DICOM report interface | Yes | Unknown |
| File based report interface | Yes | Unknown |
| URL interface for OEM integration | Yes | Unknown |
| Creation of patient media (CD, DVD)<br>according to DICOM standard | Yes | Yes |
| Hardware and Software<br>Requirements | | |
| Hardware | Pentium 2 GHz<br>512 MB RAM<br>50-100 GB Harddisk | OTS Hardware ac-<br>cording to specified<br>minimum hardware<br>requirements |
| Software | Windows 2000 Server<br>Internet Explorer 6 | Windows 2000 Server |
| | RADIN.Archive | |
| Storage Modules | | |
| DVD-R Jukebox | Yes | Yes |
| Harddisk RAID | Yes | Yes |
| Data Security | | |
| Data verification on media | Yes | Unknown |
| Manipulation detection | Yes | Unknown |
| Database consistency check | Yes | Unknown |
| Hardware and Software<br>Requirements | | |
| Product | RADIN | Thinking Net |
| Hardware | Pentium 2 GHz<br>512 MB RAM<br>50-100 GB Harddisk | OTS Hardware ac-<br>cording to specified<br>minimum hardware<br>requirements |
| Software | Windows 2000 Server<br>Internet Explorer 6 | Windows 2000 Server |
| | RADIN.Classic<br>Clients | |
| Key Features | | |
| Full DICOM images on clients | Yes | Yes |
| No Software Installation, just Internet<br>Explorer needed | Yes | Yes |
| Supported Modalities | CR, CT, DR, DS, DX,<br>ES, GM, IO, MG, MR,<br>NM, PT, OT, RF, RT,<br>US, XA, XC | CR, CT, DR, MRI,<br>MRA, US, PET |
| Supported Image Types | | |
| Greyscale | Yes | Yes |
| Color | Yes | Yes |
| Multiframe | Yes | Yes |
| Image Manipulation Functions | | |
| Zoom | Yes | Yes |
| Quick Zoom | Yes | Yes |
| Magnifying glass | Yes | Yes |
| Pan | Yes | Yes |
| Window leveling | Yes | Yes |
| Edge enhancement | Yes | Yes |
| Grayscale inversion | Yes | Yes |
| Rotating, flipping | Yes | Yes |
| MPR, MIP | No | Yes |
| Measurement Functions | | |
| Distance | Yes | Yes |
| Angulation | Yes | Yes |
| Area | No | Yes |
| Perimeter | No | Yes |
| Greyscale densitiy (probe) | Yes | No |
| Manual distance calibration | Yes | No |
| Cine Mode | Yes | Yes |
| Workflow features | | |
| Database Filters | Yes | Yes |
| DICOM query/retrieve from archives<br>and workstations | Yes | Yes |
| Product | RADIN | Thinking Net |
| Change user and group assignment of patients | Yes | Yes |
| Multiple series loading | Yes | Yes |
| Preloading of images to the client | Yes | Yes |
| Study availability status | Yes | Yes |
| Display of images together with reports | Yes | Yes |
| Easy integration with RIS/HIS systems | Yes | Yes |
| Windows Copy and Print Functions | Yes | Yes |
| Hardware and Software Requirements | | |
| Hardware | Pentium III 500 MHz,<br>(Pentium IV 2 GHz recommended)<br>128 MB RAM (512 MB recommended)<br>Standard PC graphics card, 1024 * 768 minimum resolution<br>2 GB Harddisk<br>Network or telephone adapter | OTS Hardware ac-cording to specified minimum hardware requirements |
| Software | MSWindows NT4.0, 98, 2000 or XP<br>Internet Explorer 5.5 or 6 | Microsoft Windows OS, Internet Explorer |
| Additional Features | | |
| Dual Monitor Support | Yes | No |

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### E.1.10Safety and Effectiveness

#### E.1.10.1 General Safety and Effectiveness Concerns

RADIN is a medical device that is to be used by trained health care professionals who are responsible for the correct and accurate use of medical images e.g. as a means for providing diagnosis.

The device labeling contains instructions for use and the intended use/indications for use. Warnings, faults etc are explained in the users manual.

lmages that are compressed are properly identified in the image information as being compressed as specified by the DICOM standard. This compression identification remains with the image for the entire life of the image.

#### E.1.10.2 Validation and Effectiveness

The RADIN risk analysis has been performed to identify all potential safety or health hazards during system operation. The hazards are controlled by a risk management plan, including hazard analysis, verification and validation tests (according to our software development process) and evaluations by hospitals.

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According to our risk analysis and risk management there are no software components within the RADIN Software, whose failure or latent design flaw would be expected to result in death or injury to a patient.

Requirement tracing covering specification, design, implementation and verification/validation ensures the fulfillment of all phase requirements, EHR and DMR ensures direct access to all documents.

Integration test plan defines full testing at integration and system testing level. According to this test plan integration and system testing including full testing of hazard mitigation has been performed.

Decision Reviews at the conclusion of each software development phase ensure the fulfillment of the phase results and the validity of the Intended Use and the risk analysis.

Testing is an integral part of our Software Design Process.

#### Substantial Equivalence E.1.10.3

Any differences between the RADIN Software and the substantially equivalent device have no significant influence on safety and effectiveness.

#### E.1.10.4 Technological characteristics

RADIN is a stand-alone software package used on general purpose hardware, as long as the minimum hardware requirements specified in the manuals are met.

It is based upon standard Microsoft™ technology.

The device does not contact the patient, nor does it control any life sustaining devices.

A physician, providing ample opportunity for competent human intervention interprets images and information delivered by RADIN.

#### E.1.10.5 Conclusion

SOHARD

We believe, that the 510(k) premarket notification contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device.

RADIN has been and will be manufactured in accordance with the mandatory and voluntary standards listed in this submission.

This submission contains the result of the hazard analysis and all potential hazards have been classified as minor.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 2 8 2005

SoHard, AG % Ms. Joan C. Mazur Vice President Integrated Modular Systems, Inc. 2500 W. Township Line Road P.O. Box 616 HAVERTOWN PA 19083

Re: K043483 Trade/Device Name: RADIN V3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 14, 2004 Received: December 17, 2004

Dear Ms. Mazur:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and on the FDA finding of substantial equivalence of your device to a legally premaince nonthoutine results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dosire of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Submission RADIN

11/19/2004

# D. Statement of Indications for Use

K04 3483 510(k) Number (if known): _

Device Name: RADIN Indications for Use:

RADIN can be used whenever digital images and associated data acquired or generated by different third party modalities have to be accepted, displayed, transmitted, stored, distributed, processed and archived in order to be available for professional health care personnel. RADIN is not intended to assist the healthcare personnel in diagnosis. RADIN can be used together with appropriate and proper installed computer platforms according to the recommendations made in the labeling.

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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Typical users are trained healthcare professionals including but not limited to physicians, licenced practitioners, nurses.

| Prescription Use | <span></span> | AND/OR | Over-The-Counter Use | <span></span> |
|-----------------------------|---------------|--------|------------------------|---------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | <img alt="Signature" src="signature.png"/> | Page ___ of ___ |
|---------------------------------------------------------------|--------------------------------------------|-----------------|
| Division of Reproductive, Abdominal, and Radiological Devices | | |
| 510(k) Number | K043483 | |