# K974513: Pinpoint

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: May 20, 1998 after 170 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K132108: MAXIO (2014), 27 descendants of its own
- K150313: Ablation Confirmation (2015), 16 descendants of its own
- K202297: Aline Ablation Intelligence (2020), 11 descendants of its own
- K131433: Isys 1 (U.S),Accessory, Non-Sterile (2014), 6 descendants of its own
- K220256: MIM-Ablation (2022), 4 descendants of its own

## Indications for use
The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat ‘panel TV monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. PinPoint is not limited to any particular region of the body. It is equally viable for planning head and spine interventions as it is in the abdomen. It is expected that its major use will be in the planning biopsies of abdominal organs and drainage of fluid collections in the abdomen. However, more complicated procedures such as Brachy therapy and bone pinnings will be planned using the PinPoint.

Source page: https://510kreport.com/device/K974513
Methodology: https://510kreport.com/methodology