510(k) · Cleared
ClearedEcholive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intracom Corp. · LMB Device, Digital Image Storage, Radiological
Cleared on Feb 8, 1999 as substantially equivalent to K981053 (Eastman Kodak Company, 1998) and 11 other predicates after a 61-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Feb 8, 1999
- Review
- 61 days
- Class
- Class I
- Product code
- LMB
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 3 generations to K900935 (1990). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK900935 DU Pont Linx Laser Imager W/the Linx NetworkingE.I. Dupont DE Nemours & Co., Inc. · 1990
- 2 generations backK964250 Linx Networking SystemSterling Diagnostic Imaging, Inc. · 1996
- 1 generation backK980970 Iirad Directray Operator ConsoleSterling Diagnostic Imaging, Inc. · 1998
- This deviceK984405 Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900935 | DU Pont Linx Laser Imager W/the Linx Networking | E.I. Dupont DE Nemours & Co., Inc. | 1990 | — |
| −2 | K964250 | Linx Networking System | Sterling Diagnostic Imaging, Inc. | 1996 | — |
| −1 | K980970 | Iirad Directray Operator Console | Sterling Diagnostic Imaging, Inc. | 1998 | — |
| 0 (this device) | K984405 | Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | Intracom Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (14)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981053 | Kodak Digital Sciences (KDS) Image ViewSummary page 2…ies in the particular features and capabilities it offers the medical professional. Predicate Devices: IntraCom Corporation Class | Device, 21CFR892.2020 Eastman Kodak (k981053) StorCOMM, Inc. (k973805) Sterling Diagnostic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown… | 1998 |
| * | K973805 | Imageaccess SystemSummary page 2…tures and capabilities it offers the medical professional. Predicate Devices: IntraCom Corporation Class | Device, 21CFR892.2020 Eastman Kodak (k981053) StorCOMM, Inc. (k973805) Sterling Diagnostic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k9… | 1998 |
| * | K980220 | Iisys Pacs SystemSummary page 2…edical professional. Predicate Devices: IntraCom Corporation Class | Device, 21CFR892.2020 Eastman Kodak (k981053) StorCOMM, Inc. (k973805) Sterling Diagnostic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Cor… | 1998 |
| * | K980970 | Iirad Directray Operator ConsoleSummary page 2…fessional. Predicate Devices: IntraCom Corporation Class | Device, 21CFR892.2020 Eastman Kodak (k981053) StorCOMM, Inc. (k973805) Sterling Diagnostic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Corporation (… | 1998 |
| * | K973206 | Sterling Diagnostic Imaging Direct RadiographySummary page 2…Predicate Devices: IntraCom Corporation Class | Device, 21CFR892.2020 Eastman Kodak (k981053) StorCOMM, Inc. (k973805) Sterling Diagnostic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Corporation (k972925) (… | 1997 |
| * | K964250 | Linx Networking SystemSummary page 2…Devices: IntraCom Corporation Class | Device, 21CFR892.2020 Eastman Kodak (k981053) StorCOMM, Inc. (k973805) Sterling Diagnostic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Corporation (k972925) (k954691) Oli… | 1996 |
| * | K971347 | MedisurfSummary page 2…an Kodak (k981053) StorCOMM, Inc. (k973805) Sterling Diagnostic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Corporation (k972925) (k954691) Olicon Imaging Systems, Inc. (k973959) Autocytgroup, Inc. (k970064)… | 1997 |
| * | K980648 | Pro VisionSummary page 2…k981053) StorCOMM, Inc. (k973805) Sterling Diagnostic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Corporation (k972925) (k954691) Olicon Imaging Systems, Inc. (k973959) Autocytgroup, Inc. (k970064) Indicati… | 1998 |
| * | K972925 | Access Radiology (Framewave) Teleradiology Image Acquisition and Distribution System…Summary page 2…ng Diagnostic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Corporation (k972925) (k954691) Olicon Imaging Systems, Inc. (k973959) Autocytgroup, Inc. (k970064) Indications For Use: The EchoLive™ medical image… | 1997 |
| * | K954691 | Access Radiology Teleradiology Image Acquisition & Distribution SystemSummary page 2…tic Imaging (k980220) (k980970) (k973206) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Corporation (k972925) (k954691) Olicon Imaging Systems, Inc. (k973959) Autocytgroup, Inc. (k970064) Indications For Use: The EchoLive™ medical image managemen… | 1996 |
| * | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareSummary page 2…) ) (k964250) A.L.l. Technologies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Corporation (k972925) (k954691) Olicon Imaging Systems, Inc. (k973959) Autocytgroup, Inc. (k970064) Indications For Use: The EchoLive™ medical image management device family is designed for use in a… | 1997 |
| * | K970064 | Amicas Web/Intranet Image ServerSummary page 2…gies, Inc. Unknown Algotec Systems Ltd. (k971347) (k980648) Access Radiology Corporation (k972925) (k954691) Olicon Imaging Systems, Inc. (k973959) Autocytgroup, Inc. (k970064) Indications For Use: The EchoLive™ medical image management device family is designed for use in all medical specialties includ… | 1997 |
| * | — | IntraCom Corporation Class I Device, 21 CFR 892.2020 Named without a submission number | |
| * | — | A.L.I. Technologies, Inc. Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 19 ancestors has a recall.
How does its category compare?
All LMB devicesLMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMB
FDA has decided no LMB device since 2007.
Median 510(k) review, days · LMB
Too few LMB 510(k)s in any year since 2007 to give a median.
Recalls per year · LMB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMB
7in 2025
MAUDE reports naming product code LMB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 5 | 3 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (134 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984405: Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984405
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026