510(k) · Cleared
ClearedARGOS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Line Medical Systems S.R.L. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 5, 2007 as substantially equivalent to K003589 (Brainlab AG, 2001) after a 310-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Apr 5, 2007
- Review
- 310 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003589 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003589 Vectorvision Cranial, Vectorvision Spinal, Vectorvision EntBrainlab AG · 2001
- This deviceK061479 ARGOS3D Line Medical Systems S.R.L. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent | Brainlab AG | 2001 | — |
| 0 (this device) | K061479 | ARGOS | 3D Line Medical Systems S.R.L. | 2007 | — |
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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 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? (1)
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 |
|---|---|---|---|
| * | K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision EntSummary page 1…te: January 18,2006 Device Trade Name: ARGOS Common Name: Image guided surgery system Classification name: instrument, stereotaxic. Predicate Device: Vectorvision, (K003589) manufactured by BRAINLAB AG Ammerthalstrasse 8 Heimstetten, GM 85551 Description of the Device: Argos is a system for comput… | 2001 |
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?
- Its one ancestor has no recall.
- 6 other devices also cite its predicate K003589.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
Argos is intended as an aid to the surgeon for precisely locating anatomical structures on the human body in either open or percutaneous procedures. It links tracked probes to virtual computer image space on a patient's preoperative or intraoperative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may appropriate and where the reference to a rigid anatomical structure, such as the skull, a long bone…
Read the full statement (140 words)
Argos is intended as an aid to the surgeon for precisely locating anatomical structures on the human body in either open or percutaneous procedures. It links tracked probes to virtual computer image space on a patient's preoperative or intraoperative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may appropriate and where the reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to medical images such as CT, MR, fluoroscopic or ultrasound images. Example procedures include but are not limited to:
Cranial Procedures:
Cranial biopsies
Tumor resection
Craniotomies/Craniectomies
Skull base procedures
Thalamotomies/Pallidotomies
Spinal Procedures:
Spinal implant procedures such as pedicle screw placement
ENT procedures:
Transsphenoidal procedures
Intranasal procedures
Sinus procedures, such as Maximillary anstrostomies, Ethmoidectomies
Sphenoidotomies/Sphenoid explorations, Turbinate resection and Frontal sinusotomies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061479: ARGOS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061479
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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