ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000

K984405 · Intracom Corp. · LMB · Feb 8, 1999 · Radiology

Device Facts

• Record ID: K984405
• Device Name: ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000
• Applicant: Intracom Corp.
• Product Code: LMB · Radiology
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2010
• Device Class: Class 1
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The EchoLive™ medical image management device family is designed for use in all medical specialties including, but not limited to, radiology, cardiology, gynecology, ENT, neurology, pediatrics, podiatry, chiropractic, general surgery, oral surgery and dentistry. The device may be used in medical offices and health care facilities, to facilitate access to clinical images and information, both archived and dynamic, in distributed locations over intranets, LANs, Internet, direct or dial dial-up telephone lines. The system may transmit a wide range of data including, but not limited to, Sonographs (Ultrasound images), Computer Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET). In addition the device may communicate standard audio, video and digital transmissions and recordings, providing complete clinical imaging handling, providing direct capture, retrieval, storage, and direct transmission and printing of images, reports, and patient information.

Device Story

EchoLive™ is a PACS for digital real-time simulcast transmission of medical images. Inputs include ultrasound, CT, MRI, PET, and standard audio/video/digital recordings. System facilitates capture, retrieval, storage, transmission, and printing of images, reports, and patient data. Used in medical offices and healthcare facilities by medical professionals to access archived and dynamic clinical information over intranets, LANs, Internet, or dial-up lines. Output allows clinicians to view and manage clinical imaging, supporting diagnostic workflows and patient information handling.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PACS system for digital image management. Supports DICOM, JPEG, and ISO/IEC 10918-1 compression standards. Connectivity via intranets, LANs, Internet, and dial-up. Compliant with SMPTE, NEMA, and ACR standards. Hardware meets UL 544 and IEC EN60001 safety standards.

Indications for Use

Indicated for use in all medical specialties, including radiology, cardiology, gynecology, ENT, neurology, pediatrics, podiatry, chiropractic, general surgery, oral surgery, and dentistry, to facilitate access to clinical images and information in medical offices and healthcare facilities.

Regulatory Classification

Identification

A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.

Predicate Devices

• IntraCom Corporation (K981053)
• Eastman Kodak (K973805)
• StorCOMM, Inc. (K980220)
• Sterling Diagnostic Imaging (K980970)
• A.L.I. Technologies, Inc. (K973206)
• Algotec Systems Ltd. (K964250)
• Access Radiology Corporation (K971347)
• Olicon Imaging Systems, Inc. (K980648)
• Autocytgroup, Inc. (K972925)
• Autocytgroup, Inc. (K954691)
• Autocytgroup, Inc. (K973959)
• Autocytgroup, Inc. (K970064)

Submission Summary (Full Text)

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K984405

8 1999 FEB

IntraCom Corporation EchoLive™ PACS Pre-Market Notification

## 510(K) SUMMARY STATEMENT

## Applicant:

IntraCom Corporation 1309 S. Mary Avenue Sunnyvale, ČA 94087

| Contact | James A. Nations |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | 408 569-3860 |
| Phone: | 408 735-6810 |
| Fax: | 408 735-6816 |
| E-mail: | [e-mail] |
| Manufacturing Facility: | IntraCom Corporation<br>1309 S. Mary Avenue<br>Sunnyvale, CA 94087 |
| Establishment<br>Registration Number: | Applied for, not yet received |
| Device Name: | EchoLive™ Family<br>Models: ZL-1010<br>ZL-2000<br>ZL-2100<br>ZL-3000<br>ZL-4000 |
| Common Name: | Medical Image Management Device<br>Picture Archiving and Communication Systems (PACS) |
| Device Class: | II |
| Panel: | Radiology<br>LMD<br>21 CFR 892.2050 |
| Performance Standards: | 21 CFR 820 et.seq.<br>IEC Medical Device Directive EN60001<br>UL 544<br>The Society of Motion Picture and Television Engineers<br>(SMPTE)<br>The National Electrical Manufacturers Association (NEMA)<br>American College of Radiology (ARC)<br>Digital Imaging and Communications in Medicine (DICOM)<br>IISO/IEC 10918-1 Digital Compression and Coding of<br>Continuous-Tone Still Images<br>Joint Photographic Experts Group (JPEG) |
| Reason for submission: | New PACS with substantial equivalence. |
| Product Description: | The EchoLive™ medical image management device family is a<br>PACS capable of digital real-time simulcast transmission of |

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## IntraCom Corporation EchoLive™ PACS Pre-Market Notification

.. ..

medical images. Each model varies in the particular features and capabilities it offers the medical professional.

| Predicate Devices: | IntraCom Corporation<br>Eastman Kodak<br>StorCOMM, Inc.<br>Sterling Diagnostic Imaging<br>A.L.I. Technologies, Inc.<br>Algotec Systems Ltd.<br>Access Radiology Corporation<br>Olicon Imaging Systems, Inc.<br>Autocytgroup, Inc. | Class I Device, 21CFR892.2020<br>(k981053)<br>(k973805)<br>(k980220) (k980970) (k973206)<br>(k964250)<br>Unknown<br>(k971347) (k980648)<br>(k972925) (k954691)<br>(k973959)<br>(k970064) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The EchoLive™ medical image management device<br>family is designed for use in all medical specialties including, but<br>not limited to, radiology, cardiology, gynecology, ENT, neurology,<br>pediatrics, podiatry, chiropractic, general surgery, oral surgery<br>and dentistry. The device may be used in medical offices and<br>health care facilities, to facilitate access to clinical images and<br>information, both archived and dynamic, in distributed locations<br>over intranets, LANs, Internet, direct or dial dial-up telephone<br>lines. The system may transmit a wide range of data including,<br>but not limited to, Sonographs (Ultrasound images), Computer<br>Tomography (CT), Magnetic Resonance Imaging (MRI), Positron<br>Emission Tomography (PET). In addition the device may<br>communicate standard audio, video and digital transmissions<br>and recordings, providing complete clinical imaging handling,<br>providing direct capture, retrieval, storage, and direct<br>transmission and printing of images, reports, and patient | |

information.

દર્ભ

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 8 1999

James A. Nations, Esq. Director, Regulatory Affairs IntraCom Corporation 1309 S. Mary Avenue Sunnyvale, CA 94087

Re:

K984405 EchoLive Family Models ZL-1010, 2000, 2100. 3000, 4000 Dated: November 25, 1998 Received: December 9, 1998 Regulatory class: I 21 CFR 892.2010/Procode: 90 LMB 21 CFR 892.2020/Procode: 90 LMD

Dear Mr. Nations:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

J.R. Reid, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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19844405 510(k) number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

INDICATION FOR USE:

The EchoLive medical image management device family is designed for use in all medical specialties including, but not limited to, radiology, cardiology, gynecology, ENT, neurology, pediatrics, podiatry, chiropractic, general surgery, oral surgery and dentistry. The device may be used in medical offices and health care facilities, to facilitate access to clinical images and information, both archived and dynamic, in distributed locations over intranets, LANs. Internet. direct or dial dial-up telephone lines. The system may transmit a wide range of data including, but not limited to, Sonographs (Ultrasound images), Computer Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET). In addition the device may communicate standard audio, video and digital transmissions and recordings, providing complete clinical imaging handling, providing direct capture, retrieval, storage, and direct transmission and printing of images, reports, and patient information.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescriptions Use | |
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| (per 21 CFR 801.109) | |

OR

| Over-The-Counter Use |
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| (Division Sign-Off) |
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| Division of Reproductive, Abdominal, ENT, and Radiological Devices |

| 510(k) Number | K984405 |
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| (OPTIONAL Format 1-2-96) |
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