# K983410: @ Target

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Sep 17, 1999 after 354 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
No predicates in its family tree.
344 later devices descend from it; 1 cites it directly.
3 of 345 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K020631: IPLAN (2002), 343 descendants of its own
- K040050: Instatrak System with Multiple Dataset Navigation, Model IT3500 (2004), 280 descendants of its own
- K053610: Abaris (2006), 278 descendants of its own
- K121498: Percunav (2012), 222 descendants of its own
- K132304: Epiq Diagnostic Ultrasound System (2013), 211 descendants of its own

## Indications for use
SURGERY PLANNING The SURGERY PLANNING module is a tool for pre- and intraopcrative stereotactic swigery planning based on stereotactic systems Multiple graphical digplay functions end 3-dimensional views of anatomical structures offer an effective and efficient means of presenting the anatomical datu for diagnostic and surgical planning. ‘I'he madule provides possibilities to combine and process itage data sets from CT, MRI, Angiographic, and other imaging sources. Computcr-graphic simulation in vatious views of a chosen probe path can help prevent probe intersections with unwanted, critical structuies or vessels. The surgeon can interactively change a probe path simulation through the image slices in the workstation with on-line calculation of the accompanying arc settings and graphical manipulation to aid it optimizing his approach. Its modular design makes possible adaption to the uscr’s special requirements, BRACHYTHERAPY [tus modula, hased an SURGERY PLANNING, is designed for computergraphic calculation of isodoses from implantation of radloactive seeds. implanted at given positinns within a tumor volume. The radicactive cceda are loaded into catheters tlul are implanted stereotactically. The computer software calilatas the isodose profilcs in various views or in three dimensions prior to actual seed imiplantation. The positioning of the catheters and the indwelling seeds can be dicplaycd in scverel cantours, each perpendicular tu tle direction of the implanted cathetars. The abjective is to better tsilor the dose distribution to the 3 dimensional volume of the tumar. The relevant implantation positions and other paramatars can he printed out for a hardcopy documentation of what has been duie. BRAINMAP The BRAINMAP module is a tool, which defines two and thres-dimensional informatian ahout anatomical atructures of the human brain for pre- and intrauperalive planning of stereotactic procedures.. These contours are defined and deecribed by Talairach/Tournoux and/or Schaltenbrand/Wahren based brain utfases, The user is provided with information about the position of the varioue functional and anatomical areas of the braln. These positions of the structures have to be correlated with every patients brain data. The conelatiou is delined by a procedure defined by Talalrach/Tournoux. Using their grid systam ta divide the brain in particular areas, the program will be able to provide matching dula fur different patient data. BrainMAP may be used salone or in conjunction with neurosurgery, radiotherapy and radiosurgery planning systems. FUNCTIONAL PLANNING The FUNCTIONAL PLANNING Module i3 a tool based on SURGERY PLANNING , which gives two- snd three dimensianal online information of a stereotactical surgical instrument {clectrodcs) for a neurosurgical functional treatment using a stereotactic arc. ihe usar is provided with information by numerical results and by various displays and recunstruction planes based on patient images (CT. MRI, PET, SPECY) about the pasition and orientation relative to the patient of his surgical instrumet tu pet(unin slimulation and treatment on brain structures or to a preplanned trajectory . Ihe softwara is capahle af displaying the trajectory and functional areas of the brain baced on BRAINMAP online on the screen and recording the stimulations by stoting positians of the electrodes. The FUNCTIONAL PLANNING nudule is intended to be used with patlents where measurement, stimulation and placement of electrodes in the brain {pallidotomy) are part of the treattuent, The slereotactic arc system s useful for placing these electrodes or using the inctrumente during the treatment and in the planning phases of the functional treatment.

Source page: https://510kreport.com/device/K983410
Methodology: https://510kreport.com/methodology