(61 days)
Not Found
No
The summary describes a PACS system for image management and transmission, with no mention of AI or ML capabilities.
No
The device is described as an image management system (PACS) for medical images, facilitating storage, retrieval, and transmission of diagnostic images, not directly providing therapy.
No
This device is described as an "image management device" and "PACS capable of digital real-time simulcast transmission of medical images", whose purpose is to "facilitate access to clinical images and information". It processes and transmits images from various modalities, but does not perform diagnostic interpretations itself.
Unknown
The summary describes a PACS system which is typically a combination of hardware and software. While the description focuses on the software capabilities (transmission, storage, retrieval), it doesn't explicitly state that the device is only software and does not include any proprietary hardware components.
Based on the provided information, the EchoLive™ medical image management device family is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EchoLive™ Function: The description clearly states that the EchoLive™ device is a PACS (Picture Archiving and Communication System) designed for managing and transmitting medical images from various imaging modalities (Ultrasound, CT, MRI, PET). It handles images and patient information, not biological specimens.
The device's function is focused on the handling and management of medical images generated by other diagnostic equipment, not on analyzing samples taken from the body.
N/A
Intended Use / Indications 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.
Product codes
90 LMB, 90 LMD
Device Description
The EchoLive™ medical image management device family is a PACS capable of digital real-time simulcast transmission of medical images. Each model varies in the particular features and capabilities it offers the medical professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Sonographs (Ultrasound images), Computer Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical offices and health care facilities, to facilitate access to clinical images and information
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)
K981053, K973805, K980220, K980970, K973206, K964250, K971347, K980648, K972925, K954691, K973959, K970064
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2010 Medical image storage device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
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: | nations@qpt.com |
| Manufacturing Facility: | IntraCom Corporation |
| 1309 S. Mary Avenue | |
| Sunnyvale, CA 94087 | |
| Establishment | |
| Registration Number: | Applied for, not yet received |
| Device Name: | EchoLive™ Family |
| Models: ZL-1010 | |
| ZL-2000 | |
| ZL-2100 | |
| ZL-3000 | |
| ZL-4000 | |
| Common Name: | Medical Image Management Device |
| Picture Archiving and Communication Systems (PACS) | |
| Device Class: | II |
| Panel: | Radiology |
| LMD | |
| 21 CFR 892.2050 | |
| Performance Standards: | 21 CFR 820 et.seq. |
| IEC Medical Device Directive EN60001 | |
| UL 544 | |
| The Society of Motion Picture and Television Engineers | |
| (SMPTE) | |
| The National Electrical Manufacturers Association (NEMA) | |
| American College of Radiology (ARC) | |
| Digital Imaging and Communications in Medicine (DICOM) | |
| IISO/IEC 10918-1 Digital Compression and Coding of | |
| Continuous-Tone Still Images | |
| Joint Photographic Experts Group (JPEG) | |
| Reason for submission: | New PACS with substantial equivalence. |
| Product Description: | The EchoLive™ medical image management device family is a |
| PACS capable of digital real-time simulcast transmission of |
1
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
Eastman Kodak
StorCOMM, Inc.
Sterling Diagnostic Imaging
A.L.I. Technologies, Inc.
Algotec Systems Ltd.
Access Radiology Corporation
Olicon Imaging Systems, Inc.
Autocytgroup, Inc. | Class I Device, 21CFR892.2020
(K981053)
(K973805)
(K980220) (K980970) (K973206)
(K964250)
Unknown
(K971347) (K980648)
(K972925) (K954691)
(K973959)
(K970064) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications 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.
દર્ભ
2
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON OTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescriptions Use | |
|---|---|
| (per 21 CFR 801.109) |
OR
| Over-The-Counter Use |
|---|
| ---------------------- |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K984405 |
|---|---|
| --------------- | --------- |
| (OPTIONAL Format 1-2-96) |
|---|
| -------------------------- |