# K061479: ARGOS

- Pathway: 510(k) (Traditional)
- Applicant: 3D Line Medical Systems S.R.L.
- Decided: Apr 5, 2007 after 310 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003589 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003589: Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent, Brainlab AG (2001) Summary page 1.

## Indications for use
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

Source page: https://510kreport.com/device/K061479
Methodology: https://510kreport.com/methodology