510(k) · Cleared
ClearedMediport
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxant Technologies, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 10, 2006 as substantially equivalent to K051521 (Konica Minolta Medical & Graphic, Inc., 2005) and 5 other predicates after a 14-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Feb 10, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K913475 (1991). 48 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 5 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 4 generations backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- 3 generations backK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
- 2 generations backK040344 Impax OT3000 Orthopedic WorkstationAgfa Corp. · 2004
- 1 generation backK042867 Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc. · 2004
- This deviceK060210 MediportMaxant Technologies, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −5 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −4 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| −3 | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for… | Agfa Corp. | 2002 | 9 |
| −2 | K040344 | Impax OT3000 Orthopedic Workstation | Agfa Corp. | 2004 | — |
| −1 | K042867 | Philips Orthopaedic Applications | Philips Medical Systems North America, Inc. | 2004 | — |
| 0 (this device) | K060210 | Mediport | Maxant Technologies, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K051521 | Regius RS-1000, Medical Image Processing WorkstationSummary page 2…of equivalents in order to be sure of covering all. a. Konica Minolta Medical Graphic, Inc. product REGIUS RS-1000. K051521 Paragraph 11 shows its hardware as Computer "Off the shelf" ME… | 2005 |
| * | K052461 | Syngo Imaging Version V20ASummary page 2…ell as this predicate device. This device in not quali fied for use for mammographic purposes. b. Siemens AG, Medical Solutions - K052461 Device Description "The system is a "hardware independent" solution to be distributed… | 2005 |
| * | K042867 | Philips Orthopaedic ApplicationsSummary page 3…as well as this predicate device. This device in not qualified for use for mammographic purposes. c. Phillips Orthopaedic Applications - K042867 System Description "The Phillips Orthopaedic Application software runs "off the shelf"… | 2004 |
| * | K050485 | 20.8-Inch (53CM) Monochrome LCD Monitor MDL2110A (ME351I), (DV3MM-HB)Summary page 3…ivalent to and performs as well as this predicate device. This device in not qualified for use for mammographic purposes. d. Totoku K050485, K050619 20.8" Gray scale or color 3MP monitor with DICOM calibration. Maxant is of the… | 2005 |
| * | K050619 | 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HBSummary page 3…o and performs as well as this predicate device. This device in not qualified for use for mammographic purposes. d. Totoku K050485, K050619 20.8" Gray scale or color 3MP monitor with DICOM calibration. Maxant is of the opinion t… | 2005 |
| * | K052276 | Nio 2MP-20 and E-2620 SSummary page 3…plies that meet medical standards. This device in not qualified for use for mammographic purposes. e. BarcoView K052276 20. 1" Gray scale 2MP monitor with DICOM calibration. Maxant is of the opinion that the M… | 2005 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 11 of the 48 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The MEDIPORT is a medical grade device to be used as a platform for PACS software or DICOM viewer software. It is intended for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories.
In light of the fact that MEDIPORT is a high performance computer it may also be used to access patient records or perform other functions that may be required.
This device in not qualified or intended for use for mammographic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060210: Mediport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060210
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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