VIEWSEND MEDICAL SYSTEM

K051586 · Kenei Co., Ltd. · LLZ · Aug 4, 2005 · Radiology

Device Facts

• Record ID: K051586
• Device Name: VIEWSEND MEDICAL SYSTEM
• Applicant: Kenei Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

When installed on an appropriate PC-based platform, the VIEWSEND Medical System is intended to provide the medical professional with the capability to compare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis. Digital image storage in system RAM and hard drive standard is with lossless compression or without data compression. Options include teleradiology, telemedicine, videoconferencing, communications, viewer, customizable database, DICOM 3.0, stand-alone or client/server or web-based, compression, and/or security. Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers. 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 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA

Device Story

VIEWSEND Medical System is a modular software suite for telemedicine, teleradiology, and videoconferencing. Inputs include medical images (DICOM 3.0) and video/audio feeds from cameras (e.g., Canon VCC4) and document visualizers. The system runs on Windows-based PCs; it enables image viewing, manipulation, annotation, and transmission over various networks (LAN, ISDN, POTS). It supports DICOM query/retrieve/send/receive/print. Healthcare providers use the system to collaborate and review images remotely. It does not provide automated diagnostic recommendations. Benefits include improved access to diagnostic imaging and remote clinical consultation. The system uses standard compression (lossless/lossy) and encryption (AES 128-bit).

Clinical Evidence

Bench testing only. No clinical data provided. Software functional requirements were verified and validated through test plans, including regression testing for incremental revisions.

Technological Characteristics

PC-based software; C++ object-oriented architecture. Supports DICOM 3.0, JPEG 2000 (ISO 15444-1), and AES 128-bit encryption. Connectivity via TCP/IP, ISDN, POTS. Hardware components include video codecs (Zydacron, VCON), CCD cameras, and medical-grade grayscale monitors. Software is modular; includes DICOM toolkits from Merge Technologies and JPEG 2000 routines from Pegasus.

Indications for Use

Indicated for medical professionals to compare, manipulate, annotate, collaborate, and transmit medical images for diagnostic purposes. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images.

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

• VIEWSEND Medical Products (K962225)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "KOJI586" written in a handwritten style. The letters and numbers are all connected, and the text is written in black ink. The text appears to be a code or a name.

AUG 4 - 2005

## SECTION 3

# SECTION 510(k) SUMMARY

The following information was completed on May 31, 2005. It is submitted in compliance with the provisions of 21 CFR 807.92:

807.92 (a)(1)

- Submitter's Name: (a)
Kenei Co., Ltd 5-13-9 Higashi Ueno Taito-ku Tokyo, Japan 110-0005

- Contact Person: (b)
Jennifer Li 6899 Churchill Road McLean, Virginia 22102 Telephone: [phone] Facsimile: 703-905-8038 Email: [e-mail]

## 807.92 (a)(2)

- Device Name: (a)
VIEWSEND Medical System

- Trade/Proprietary/Common Name: (b)
VIEWSEND Medical VIEWSEND Medical 7 (Plus and Lite) VIEWSEND Medical 7.5 (Plus and Lite) VIEWSEND Telemed DICOM Server VIEWSEND RAD Plus and Lite; Client Station, Viewing Station

- Classification Name: System, Image Processing, Radiological (c)
#### Identification of Legally Marketed Device to Which Kenei Claims Equivalence 807.92 (a)(3)

The VIEWSEND Medical System is equivalent to a legally marketed predicate system; specifically, VIEWSEND Medical Products marketed by KLT Telecom, Inc. ("KLT") pursuant to an authorization issued by CDRH on October 25, 1996 (K-962225).

#### Identification of Device That is Subject of this Premarket Notification Submission 807.92 (a)(4)

The VIEWSEND Medical System is a modular software program providing telemedicine, teleradiology, and videoconferencing capabilities. The system may also utilize some or all of the following components:

#### (1) DICOM

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· Image file format complies with industry standard DICOM 3.0 protocols; and

- · Query, retrieve, send, receive, DICOM Direct, and DICOM print all conform with DICOM 3.0 protocols.
- (2) Zydacron

• Features:

User Interface:

Full feature video teleconferencing application

## Audio:

Standards: G.711, G.722, and G.728 One line level input/output Balanced microphone input Amplified speaker output RJ-11 jack to connect to standard POTS telephone or fax machine Hook and DTMF detection for dialing Automatic gain control Full duplex echo cancellation Noise suppression

## Video:

Standards: H.261 Two video inputs S-video or composite NTSC or PAL Analog VGA input from VGA board, no feature connector VGA output CIF/QIF resolution PIP window

### Data:

Built in file transfer and messaging commands Serial port emulation supports popular groupware applications Optional network emulation supports TCP/IP applications

### Comm Board Options - Signaling Standards: H 320, H.221, H.230, H.242, H.243

ISDN-BRI/PRI Ethernet Iso-Ethernet V 35 Interface MVIP compatible boards

### Customization Options:

ZDK for custom application development Installation kits for custom install disk and manuals Call control development kit for integrating new communication systems Host comm. development kit for integrating host bus based communication system

#### (3) Canon Communication Camera

-
- Features:

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| Video Signal: | TCC video signal |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Sensor: | 1/3-inch CCD |
| Total # of Pixels: | 410,000 pixels |
| Synchronization: | Internal |
| Horizontal Resolution: | 450 TV lines |
| Vertical Resolution: | 350 TV lines |
| S/N ratio: | 43dB |
| Scanning Method: | 2 : 1 interlace |
| Pan Mechanism: | Rotation angle: RT-LT (+ or -) 50 degress.<br>Rotation speed: Maximum of 38 degress/second |
| Tilt Mechanism: | Rotation angle: RT-LT (+ or -) 20 degress.<br>Rotation speed: Maximum of 35 degress/second |
| Input Terminal: | MIC IN mini-jack x 1 (input impedance approx. 5k ohms) |
| Output Terminal: | Audio Out: pin jack x 1 (O/P impedance approx. 1k ohms)<br>Video Out: pin jack x 1 (O/P impedance approx. 75 ohms)<br>S Video Out: S-video jack x 1 (O/P impedance approx. 75 ohms) |
| Control Terminal: | RS-232C: Mini DIN x 1<br>Communication Standards: RS-232C level<br>Data Bit: 8 bit<br>Parity: None<br>Stop Bit: 2 bit<br>Handshake: RTS/CTS control |
| Focusing: | Auto/Manual |
| Iris Adjustment: | Auto iris servo system |
| Lens: | f/1/8 -2.6 8x power zoom 6-48 mm focal length |
| White Balance: | TTL system, full auto white balance |
| Power Supply/Other: | Pwr Source: Commercial power supply 120V AC, 60Hz<br>Pwr. Consumption: Max. 17W (AC adapter included)<br>Weight: Approx. 2.2 lbs. (1kg)<br>Dimensions: 4 15/16 x 6 1/4 x4 1/16"<br>(125 x 158 x 103 mm)<br>Temp. Hum.: 41 F-95 F (5C-35C), 20% - 85 |

.

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| Wireless Controller: | Angle: (+ or -) 30 degrees from a hoz. position |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Type :<br>System:<br>Pwr. Supply:<br>Dimensions: | WL-V1<br>Infrared pulse system<br>DC 3V (Two R6/AA batteries)<br>1 13/16 x 6 11/16 x 11/16 inches<br>(45 x 169.5 x 19 mm) |
| AC adapter: | Type:<br>Input Level:<br>Output Level:<br>Polarity:<br>Dimensions:<br>Weight: |
| | PA -V6<br>120 V AC 60Hx 27VA<br>12 V DC 1.5 A (max)<br>Outside (-)<br>2 1/4 x 3 15/16 x 1 7/8 inches<br>(58 x 100 x 49 mm)<br>Approx. 1.4lbs (690g) |

#### COHERENT Call Port Display Audio Conferencing System (4)

## • FEATURES:

# Frequency Response (1 kHz reference)

| | Transmit: | 200 Hz to 3.4 kHz (+ or - 1dB) |
|-------------------------|------------------------------|---------------------------------------------------------------------------------------------|
| | Receive: | 200 Hz to 3.4 kHz (+ or - 1dB) |
| Harmonic Distortion: | Microphone to audio output: | 0.5% maximum |
| | Audio Input to Loudspeaker: | 0.1% maximum at 1 watt output (1kHz |
| Audio Power: | | 3 watts peak to loudspeaker |
| Dynamic Range: | | 70 dB minimum |
| Echo Control: | Acoustic Tail Circuit Delay: | 68 mS |
| | Center Clipper (NLP): | Adaptive |
| | AERL Enhancement: | 65 dB min. with NLP enabled<br>Continuously adaptive echo cancellation during normal speech |
| Input/Output Impedance: | Input: | Headphone 10 k ohms<br>Line 50 k ohms |
| | Output: | Microphone 100 ohms<br>Line 50 ohms |
| Normal Levels: | Input: | Headphone -25 dBm<br>Line -33 dBm |
| | Output: | Microphone -58 dBm<br>Line -27 dBm |
| Power Requirements: | | Power is derived using the 120 VAC power supply included with the Call Port |

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#### Canon RE-650 MKH Video Visualizer Document Camera (5)

## • FEATURES:

. .

.

| Video Signal: | Conforms to NTSC color Format | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Pick-up Element: | 1/3 - inch CCD | |
| Total # of Pixels: | 410,000 (811H X 508V) | |
| Synchronization: | Internal | |
| Horizontal Resolution: | 450 TV Line | |
| Vertical Resolution: | 350 TV Lines | |
| S/N: | 46dB | |
| White Balance: | Automatically adjusted | |
| Negative/<br>Positive<br>Conversion: | Possible | |
| Input Source: | Camera head and two (2) other sources | |
| Input/Output<br>Terminals: | Video In<br>Video Out<br>S-Video Out<br>Audio In<br>Audio Out<br>Mic In<br>AC outlet | Pin jack x 2<br>Pin jack x 2<br>S-Video jack x 1<br>Pin jack x 2<br>Pin jack x 2<br>Mini-jack x 1<br>120VAC, 5A max. |
| External<br>Input<br>Microphone | Input Impedance: 450 to 1,200 ohms (mini jack) | |
| Lens (for Rear<br>Position) | Zoom Lens, 5.2 62.4 mm f/1.8 - 2.8 (8 - group 10 - group) | |
| Document table<br>Lens: | 500 mm close-up lens (1 - group 2 - clement) | |
| Ranges: | 16 - 7/32" x 12 - 13/32" to 1 - 13/32" x 1 - 1/16"<br>(412 x 315 mm to 35.5 x 27mm) NORMAL position<br>12 -5/8' x 9- 29/64" to 1 -13/64" x 7/8"<br>(320 x 240 mm to 30.5 x 22.5 mm) in CLOSE UP position | |
| Zoom: | Power Zoom | |
| Focusing: | Auto/Manual | |
| Iris<br>Adjustment: | Automatically adjusted (fine-adjustable) | |
| | Zoom<br>Position<br>Memory: | Zoom position setting saved when power turned off |
| | Electronic<br>Shutter: | Two (2) settings, 1/60 and 1/100 |
| | Camera<br>Head<br>Positions: | NORMAL, CLOSE-UP, REAR |
| | Illumination: | 6W fluorescent lamp (FL6W) x 2, angle-adjustable |
| | Outside<br>Dimension: | 26 - 1/16" (W) x 26- 3/4: (H) x 21 - 3/4" (D)<br>(662 (W) x 680 (H) x 553 (D) mm) |
| | Stored<br>Dimension: | 15 -3/4" (W) x 8 -1/16" (H) x 21 -3/4" (D)<br>(400 (W) x 205 (H) x 553 (D) mm) |
| | Weight: | Approx. 22lbs (10kg) |
| | Power<br>Source: | 120VAC 60Hz |
| | Power<br>Consumption: | 25 W |
| 807.92 (a)(5) | Intended Uses and Indications. | |
| | See Section 2 above | |
| 807.92 (a) (6) | Technological Characteristics | |

:

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Introduction (i)

The VIEWSEND Medical System is a modular software program providing telemedicine, teleradiology, and videoconferencing capabilities. The software can be installed and tellediedle, telefonderstogy and of these capabilities as shown in Table 3-1.

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| VIEWSEND<br>Medical<br>Version | Telemedicine | Videoconferencing | Collaboration | DICOM | Communications | Viewer | Storage | Customizable DB | Stand Alone | Client/Server | Web-based | Compression | Security |
|--------------------------------|--------------|-------------------|---------------|-------|----------------|--------|---------|-----------------|-------------|---------------|-----------|-------------|----------|
| Plus/Lite | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ |
| RAD Workstation | | | ✓ | ✓ | ✓ | ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ |
| RAD Viewer | | | | ✓ | ✓ | ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ |
| MDOffice | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | | | | | | |
| RIX | ✓ | | | ✓ | ✓ | ✓ | | | | | | ✓ | |
| Web-RIX | ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ | | | ✓ | ✓ | |
| Server | | | | ✓ | | | ✓ | ✓ | | | | | |

#### Table 3-1

. .

## Version names for common VIEWSEND Medical installation options

- System Specifications (ii)
The following minimum hardware and software components have been qualified for use with the VIEWSEND Medical System (not all items listed are required for install or use):

| (b) | Operating Systems<br>Windows 2000 Workstation |
|-----|-----------------------------------------------|
| | Window XP Professional (Service Pack 2) |
| | Windows NetMeeting 2.1, 3.x |
| (c) | Hardware |
| | Pentium IV - 1.8 GHz processor |
| | 512 MB Ram |
| | 80 GB Hard disk drive |
| | Zydacron Z350, Z360 Video Codec |
| | VCON Escort, Cruiser Video Codec |
| | ISDN Telecommunication Board |
| | Video capture card |
| | 56K Modem |
| | Network Interface Card |
| | Mouse/Keyboard |
| | Video Camera |
| | Mic & Speaker combination |
| (ત) | |
| (c) | Displays |
| | |

The medical professional will follow their current industry standard recommendations for clinical and diagnostic display - currently minimum 1.5K x 2.0K resolution for diagnostic purposes.

Clinical display - 17" SVGA monitor at 1024x768 screen resolution

Diagnostic Display - Medical Grayscale monitor(s) at 1.5 x 2.0k resolution with medical grade graphics board

#### (f) Compression

The VIEWSEND Medical System complies with the following standard adopted by the American College of Radiology (ACR Standard for Digital Image Data Management, 1998 Res.15):

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"Data compression may be performed to facilitate transmission and storage. Several methods, including both reversible and irreversible techniques, may be used under the direction of a qualified physician, with no reduction in clinical diagnostic image quality. The types and ratios of compression used for different imaging studies transmitted and stored by the system should be selected and periodically reviewed by the responsible physician to ensure appropriate clinical image quality."

Diagnostic wet reads can be made according to radiologist industry standard recommendations. Currently radiologists require medical grade grayscale monitors and uncompressed iccommendations: "Currenty factoregion required and used according to ACR's guidelines mage tornator's discretion. VIEWSEND Medical is compliant with these requirements.

Lossy compression will be apparent to the reader when using the VIEWSEND Medical System. As shown in Figure 3-1 below, the compression applied to an image can be displayed. In this way, both the compression mechanism and the ratio can be seen.

| Patient | DOE JOHN |
|-----------------------|--------------------------|
| Anatomy | CHEST |
| Birthdate: | 1954.12.31 |
| Series Date: | 2002.01.03 |
| Series Time: | 13:56:21 |
| FileType: | DICOM JPEG LOSSY 12-bits |
| Modality: | CR |
| Compression Ratio | 14.8 : 1 |
| Bit Depth: | 16-bit |
| Image Pixel Size: | 880 x 1068 |
| Series File Size (KB) | 127 |
| No. of Images: | 1 |

Figure 3-1 Image Compression Information

- Checklist (d)
The Section 510(k) Summary Checklist follows immediately after this Section 3.

#### Incremental Technological Improvements to Predicate Device 807.92 (a)(6)

The VIEWSEND Medical System includes incremental technological features which have been added to the predicate device as indicated in Section 1, 807.87(g) and Chart 1-1 above

Other Information - Safety and Effectiveness. 807.92 (d)

The following information will provide certification as to the subject of safety and effectiveness analysis.

The VIEWSEND Medical System is comprised of modular software that provides telemedicine, teleradiology and videoconferencing capabilities. This system is desail in Section 1 above. Further, the software has been evaluated in accordance with CDRH's "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review". Based on this review, a Our level of concern was assigned to the software. Provided below is a discussion of the software's development process.

VIEWSEND Medical was developed based on an off-the-shelf medical software product known as Osiris 2.5. The Osiris 2.5, a Windows-based radiology package, was developed by University of Geneva Medical Center as part of its PACS system. The Osiris software is built upon C++ object oriented methodology with well-defined interface for each software module. C++ exception handling is built in to minimize system malfunction and to provide a graceful system exit without data loss. All DICOM routines are from Merge Technologies. JPEG 2000 routines are from Pegasus.

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VIEWSEND Medical provides image transmission and storage. TCP/IP protocol is used to guarantee reliable image transmissions among VIEWSEND Medical workstations in local and wide arca networks. Zmodem and FTP protocols are used as well for direct modem-to-modem connections.

As established with the unmodified device, and as stated as the intended use of both the unmodified and the modified device, VIEWSEND Medical System software does NOT:

- Threaten the patient's life �
- Cause irreversible illness or injury �
- Directly control delivery of energy �
- Administration of parental drugs �
- Perform life-sustaining functions �
- Provide alarms for life threatening conditions �
- Provide a diagnosis recommendation or statement (such as an expert system) �

In addition, it has always been maintained, and supported by ACR, that healthcare professionals shall exercise their own judgment when using the displayed information for diagnosis.

Standard software development policy/procedures were followed by Kenei's predecessor in order to provide quality assurance. Test plans were developed in the process and used for testing, vertication and validation tasks. Testing results demonstrated that the software functional requirements were met, and that the software specifications were fulfilled.

The following matrix is provided as a summary to demonstrate that Kenei's predecessor has sufficiently analyzed the safety of each incremental software revision, established the basis for appropriate development, and implemented safety/performance requirements.

| | Incremental Software<br>Revisions | A | B | C | D | E | F | G | Comment | Hazard<br>Level of<br>Concern |
|----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|---|----|---|---|---|--------------------------------------------------------------------------------|-------------------------------|
| | User Interface Updates | | | | | | | | | |
| 1 | Added Patient Work List with<br>read/unread status indicators | N | N | N | N | Y | Y | N | | Minor |
| 2 | Added user preferences tool | N | N | N | N | Y | Y | N | | Minor |
| 3 | Added floating toolbar | N | N | N | N | Y | Y | N | | Minor |
| 4 | Single address book is used<br>for systems configured with<br>both H.320 and H.323<br>standards | N | N | Y | N | Y | Y | N | | Minor |
| 5 | Revised the toolbar to flatbar<br>standard with support for<br>various screen resolutions | N | N | N | N | Y | Y | Y | | Minor |
| 6 | Added window width/level<br>presets | N | N | Y | N | Y | Y | Y | | Minor |
| 7 | Added Japanese localization | N | N | N | N | Y | Y | Y | Localization<br>completed by Akira<br>Tanaka, Melon<br>System, Inc.,<br>Japan | Minor |
| | Incremental Software<br>Revisions | A | B | C | D | E | F | G | Comment | Hazard<br>Level of<br>Concern |
| | User Interface Updates | | | | | | | | | |
| 8 | Viewer now follows radiology<br>workflow more closely | N | N | N | N | Y | Y | Y | | Minor |
| | Feature Additions | | | | | | | | | |
| 9 | Enable or disable the<br>automatic forwarding<br>capability of patient<br>information received by<br>VIEWSEND Medical station<br>to another DICOM station | N | N | N | N | Y | Y | N | | Minor |
| 10 | Enable or disable the lossless<br>compression capability for<br>each transfer item in the<br>transfer list queue | N | N | N | N | Y | Y | Y | | Minor |
| 11 | Enable or disable the FTP<br>transfer capability before<br>each consultation session. If<br>FTP transfer is enabled<br>before the connection<br>process occurs, VIEWSEND<br>Medical station will attempt<br>to establish an FTP link to be<br>used for all the file transfer<br>activities during the<br>subsequent consultation<br>session | N | N | N | N | Y | Y | Y | | Minor |
| 12 | Added VIEWSEND log file to<br>detail the actions performed<br>during use | N | N | N | N | Y | Y | N | | Minor |
| 13 | Added DICOM interface to<br>include query, retrieve, send,<br>receive, print, and DICOM<br>Dir | N | N | N | N | Y | Y | Y | DICOM toolkit<br>provided by Merge<br>for all data<br>transfer | Minor |
| 14 | Added store and forward e-<br>mail send capability | N | N | N | N | Y | Y | Y | | Minor |
| 15 | Added dual video source<br>switching | N | N | N | N | Y | Y | N | | Minor |
| 16 | Added capability of saving<br>video captured images and<br>scan images into DICOM<br>secondary capture image<br>format | N | N | N | Y* | Y | Y | N | * Used same<br>algorithm as with<br>film images in the<br>unmodified device | Minor |
| | Incremental Software<br>Revisions | A | B | C | D | E | F | G | Comment | Hazard<br>Level of<br>Concern |
| 17 | Added the capability to<br>automatically forward study<br>information received from<br>DICOM modalities using<br>DICOM Send. In addition,<br>study information received<br>from another VIEWSEND<br>Medical station during<br>collaboration can be<br>automatically forwarded<br>using DICOM Send | N | N | N | N | Y | Y | N | | Minor |
| 18 | Application sharing is now<br>available for VIEWSEND<br>Medical systems configured<br>with H.320 standard- | N | N | N | N | Y | Y | Y | | Minor |
| | Software/Hardware<br>Support | | | | | | | | | |
| 19 | VIEWSEND is now a 32-bit<br>application | N | N | N | N | Y | Y | N | NT/Win2K 32-bit<br>support provided<br>by C++<br>development code | Minor |
| 20 | Added industry standard<br>JPEG2000 compression<br>option - ISO International<br>Standard, IS 15444 Part 1.<br>The 'Joint' in Joint<br>Photographic Experts Group<br>refers to the link with ITU-T,<br>and IS 15444-1 will also be<br>an ITU-T Recommendation,<br>T.800 | N | N | N | Y* | Y | Y | Y | * Used ISO<br>international<br>standard in toolkit<br>from Pegasus | Moderate |
| 21 | Added capability to print<br>overlays and image to laser<br>printer | N | N | N | N | Y | Y | N | | Minor |
| 22 | Added industry standard<br>128-bit encryption option.<br>The encryption algorithm is<br>based on the standard<br>Rijndael algorithm, as<br>specified in the Advanced<br>Encryption Standard (AES)<br>developed by the U.S.<br>National Institute of<br>Standards and Technology<br>(NIST). The AES is a block<br>cypher that uses long keys<br>(128-, 192-, 256-bit) for data<br>encryption | N | N | N | Y* | Y | Y | N | * Used industry<br>standard 128-bit<br>algorithm provided<br>by Microsoft (MS) | Minor |
| 23 | Added support for Zydacron<br>350, 360 and VCON escort, | N | N | N | N | Y | Y | Y | | Minor |
| | Incremental Software<br>Revisions | A | B | C | D | E | F | G | Comment | Hazard<br>Level of<br>Concern |
| 24 | Added support for Cannon<br>VCC4 camera | N | N | N | N | Y | Y | N | | Minor |
| 25 | Added MS SQL client/server<br>support | N | N | N | N | Y | Y | Y | | Minor |
| 26 | Added PowerPoint<br>Presentation support in<br>videoconferencing | N | N | N | N | Y | Y | Y | | Minor |
| 27 | Added MPEG4 video format<br>support | N | N | N | N | Y | Y | Y | | Minor |

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- A Could the failure or latent design flaw in this revision immediately threaten the patient's life under plausible conditions?
- B Could the failure or latent design flaw in this revision directly cause irreversible illness or permanent injury under plausible conditions?
- C Does the failure or latent design flaw in this revision consolidate or obscure information or data that is available to the user in the unmodified device?
- D Could software errors in this revision potentially lead to diagnostic or monitoring information to be missed or inaccurate?
- E Were software specifications, requirements, and design set forth for this revision?
- F Was this revision verified and validated through KLT testing criteria?
- G Was regression testing required to maintain this revision?

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Image /page/12/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to convey the department's mission of protecting the health of all Americans and providing essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 - 2005

Kenei, Co., Ltd. % Ms. Jennifer Li United States Agent Vanguard Solutions Technology, LLC 6899 Churchill Road MCLEAN VA 22101

Re: K051586

Trade/Device Name: VIEWSEND Medical System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: LLZ Dated: June 2, 2005 Received: June 16, 2005

Dear Ms. Li:

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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, primits wourderice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation punther 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/industry/support/index.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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# Indications for Use

510(k) Number (if known): K051586

Device Name: VIEWSEND Medical System

Indications For Use:

The indications for use of the VIEWSEND Medical System, as described in its labeling, are the same as the previously cleared devices marketed and distributed by KLT telecom, Inc. (K-962225). The VIEWSEND Medical System has the same intended use as the originally cleared device.

When installed on an appropriate PC-based platform, the VIEWSEND Medical System is intended to provide the medical professional with the capability to comnare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis. Digital image storage in system RAM and hard drive standard is with lossless compression or without data compression. Options include teleradiology, telemedicine, videoconferencing, communications, viewer, customizable database, DICOM 3.0, stand-alone or client/server or web-based, compression, and/or security.

Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers.

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 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R051586
Division Sign-Off

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K05/9

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