Predicate Devices

K-962225

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a system for image comparison, manipulation, annotation, collaboration, and transmission, focusing on standard telemedicine and teleradiology functionalities. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML-powered devices.

Therapeutic

No
The device is described as a "modular software program providing telemedicine, teleradiology, and videoconferencing capabilities" that allows medical professionals to "compare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis." It does not directly treat or diagnose a disease state.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that the system is "intended to provide the medical professional with the capability to ... transmit medical images in order to render a diagnosis." This explicitly indicates its role in the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system "may also utilize some or all of the following components," which include hardware components like cameras and audio conferencing systems. While the core is software, it is designed to integrate with and utilize specific hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is focused on the manipulation, comparison, annotation, collaboration, and transmission of medical images for the purpose of rendering a diagnosis. This is related to medical imaging and diagnosis based on visual information, not on analyzing biological samples or substances from the human body.
Device Description: The device is described as a software program with capabilities for telemedicine, teleradiology, and videoconferencing, utilizing components related to image handling and communication.
Input Imaging Modality: The inputs are medical images from various sources (DICOM, video, scans).
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.

The device falls under the category of medical image management and viewing systems, which are distinct from IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

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
(2) Zydacron
(3) Canon Communication Camera
(4) COHERENT Call Port Display Audio Conferencing System
(5) Canon RE-650 MKH Video Visualizer Document Camera

Mentions image processing

System, Image Processing, Radiological

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professional / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K-962225

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

Summary

0

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: 703-905-8038 Facsimile: 703-905-8038 Email: jennli@viewsend.com

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

1

· 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:

2

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.
Rotation speed: Maximum of 38 degress/second
Tilt Mechanism:	Rotation angle: RT-LT (+ or -) 20 degress.
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)
Video Out: pin jack x 1 (O/P impedance approx. 75 ohms)
S Video Out: S-video jack x 1 (O/P impedance approx. 75 ohms)
Control Terminal:	RS-232C: Mini DIN x 1
Communication Standards: RS-232C level
Data Bit: 8 bit
Parity: None
Stop Bit: 2 bit
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
Pwr. Consumption: Max. 17W (AC adapter included)
Weight: Approx. 2.2 lbs. (1kg)
Dimensions: 4 15/16 x 6 1/4 x4 1/16"
(125 x 158 x 103 mm)
Temp. Hum.: 41 F-95 F (5C-35C), 20% - 85

.

3

Wireless Controller:	Angle: (+ or -) 30 degrees from a hoz. position
Type :
System:
Pwr. Supply:
Dimensions:	WL-V1
Infrared pulse system
DC 3V (Two R6/AA batteries)
1 13/16 x 6 11/16 x 11/16 inches
(45 x 169.5 x 19 mm)
AC adapter:	Type:
Input Level:
Output Level:
Polarity:
Dimensions:
Weight:
	PA -V6
120 V AC 60Hx 27VA
12 V DC 1.5 A (max)
Outside (-)
2 1/4 x 3 15/16 x 1 7/8 inches
(58 x 100 x 49 mm)
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
Continuously adaptive echo cancellation during normal speech
Input/Output Impedance:	Input:	Headphone 10 k ohms
Line 50 k ohms
	Output:	Microphone 100 ohms
Line 50 ohms
Normal Levels:	Input:	Headphone -25 dBm
Line -33 dBm
	Output:	Microphone -58 dBm
Line -27 dBm
Power Requirements:		Power is derived using the 120 VAC power supply included with the Call Port

4

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/
Positive
Conversion:	Possible
Input Source:	Camera head and two (2) other sources
Input/Output
Terminals:	Video In
Video Out
S-Video Out
Audio In
Audio Out
Mic In
AC outlet	Pin jack x 2
Pin jack x 2
S-Video jack x 1
Pin jack x 2
Pin jack x 2
Mini-jack x 1
120VAC, 5A max.
External
Input
Microphone	Input Impedance: 450 to 1,200 ohms (mini jack)
Lens (for Rear
Position)	Zoom Lens, 5.2 62.4 mm f/1.8 - 2.8 (8 - group 10 - group)
Document table
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"
(412 x 315 mm to 35.5 x 27mm) NORMAL position
12 -5/8' x 9- 29/64" to 1 -13/64" x 7/8"
(320 x 240 mm to 30.5 x 22.5 mm) in CLOSE UP position
Zoom:	Power Zoom
Focusing:	Auto/Manual
Iris
Adjustment:	Automatically adjusted (fine-adjustable)
	Zoom
Position
Memory:	Zoom position setting saved when power turned off
	Electronic
Shutter:	Two (2) settings, 1/60 and 1/100
	Camera
Head
Positions:	NORMAL, CLOSE-UP, REAR
	Illumination:	6W fluorescent lamp (FL6W) x 2, angle-adjustable
	Outside
Dimension:	26 - 1/16" (W) x 26- 3/4: (H) x 21 - 3/4" (D)
(662 (W) x 680 (H) x 553 (D) mm)
	Stored
Dimension:	15 -3/4" (W) x 8 -1/16" (H) x 21 -3/4" (D)
(400 (W) x 205 (H) x 553 (D) mm)
	Weight:	Approx. 22lbs (10kg)
	Power
Source:	120VAC 60Hz
	Power
Consumption:	25 W
807.92 (a)(5)	Intended Uses and Indications.
	See Section 2 above
807.92 (a) (6)	Technological Characteristics

:

5

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.

6

| VIEWSEND
Medical

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
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):

7

"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.

8

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

9

10

11

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?

12

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.

,

•
•

13

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 (800) 638-2041 or (301) 443-6597 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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