510(k) · Cleared
ClearedARGOS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Santec Corporation · MXK Device, Analysis, Anterior Segment
Cleared on May 16, 2019 as substantially equivalent to K150754 (Santec Corporation, 2015) and 2 other predicates after a 27-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- May 16, 2019
- Review
- 27 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K896095 (1990). 41 ancestors in all, the oldest K781994 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- 2 generations backK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- 1 generation backK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
- This deviceK191051 ARGOSSantec Corporation · 2019
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 6 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 5 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 4 generations backK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- 3 generations backK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- 2 generations backK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- 1 generation backK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
- This deviceK191051 ARGOSSantec Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −6 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −5 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −4 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| −3 | K141068 | Zeiss Cataract Suite Markerless | Carl Zeiss Meditec, AG | 2014 | — |
| −2 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| −1 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
| 0 (this device) | K191051 | ARGOS | Santec Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 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 MXK? 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 MXK device
- #1 K251848 Pentacam® Cornea OCTscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K150754 | ARGOSSummary page 5…substantially equivalent to the predicate device identified previously: • the ARGOS (Santec Corporation) that was cleared by the FDA on October 2nd, 2015(K150754) as the primary predicate as it has the most similar intended use and characteristics • the IOLMaster 700 (Carl Zeiss… | 2015 |
| * | K143275 | IOLMaster700Summary page 5…ate as it has the most similar intended use and characteristics • the IOLMaster 700 (Carl Zeiss Meditec) that was cleared by the FDA on June 29, 2015 (K143275, K170171) as an additional (secondary) predicate to support a new feature of reference image capture on the version of AR… | 2015 |
| * | K170171 | IOLMaster 700Summary page 5…has the most similar intended use and characteristics • the IOLMaster 700 (Carl Zeiss Meditec) that was cleared by the FDA on June 29, 2015 (K143275, K170171) as an additional (secondary) predicate to support a new feature of reference image capture on the version of ARGOS in th… | 2017 |
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 29 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 41 ancestors have a recall of any class.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MXK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXK
Too few MXK 510(k)s in any year since 2007 to give a median.
Recalls per year · MXK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXK
1in 2025
MAUDE reports naming product code MXK, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest…
Read the full statement (110 words)
ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White-to-white (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.
It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191051: ARGOS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191051
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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