# K984405: Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000

- Pathway: 510(k) (Traditional)
- Applicant: Intracom Corp.
- Decided: Feb 8, 1999 after 61 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K900935 (1990). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981053: Kodak Digital Sciences (KDS) Image View, Eastman Kodak Company (1998) Summary page 2.
- K973805: Imageaccess System, Storcomm, Inc. (1998) Summary page 2.
- K980220: Iisys Pacs System, Sterling Diagnostic Imaging, Inc. (1998) Summary page 2.
- K980970: Iirad Directray Operator Console, Sterling Diagnostic Imaging, Inc. (1998) Summary page 2.
- K973206: Sterling Diagnostic Imaging Direct Radiography, Sterling Diagnostic Imaging, Inc. (1997) Summary page 2.
- K964250: Linx Networking System, Sterling Diagnostic Imaging, Inc. (1996) Summary page 2.
- K971347: Medisurf, International Regulatory Consultants (1997) Summary page 2.
- K980648: Pro Vision, Algotec Systems, Ltd. (1998) Summary page 2.
- K972925: Access Radiology (Framewave) Teleradiology Image Acquisition and Distribution System with Picture and Archiving Communic, Access Radiology Corp. (1997) Summary page 2.
- K954691: Access Radiology Teleradiology Image Acquisition & Distribution System, Access Radiology Corp. (1996) Summary page 2.
- K973959: Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software, Olicon Imaging Systems, Inc. (1997) Summary page 2.
- K970064: Amicas Web/Intranet Image Server, Autocyt Group, Inc. (1997) Summary page 2.
- (no number) IntraCom Corporation Class I Device, 21 CFR 892.2020: named in the summary without a submission number
- (no number) A.L.I. Technologies, Inc.: named in the summary without a submission number

## 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, LANSs, 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.

Source page: https://510kreport.com/device/K984405
Methodology: https://510kreport.com/methodology