# K970819: Targobeam

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Jul 14, 1997 after 131 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hawkins Blunt Needle Access System (Medical Device Technologies): named in the summary without a submission number
- (no number) SiteRite II Vascular Access Guidance System (Dymax Corporation): named in the summary without a submission number
- (no number) ColorMark (EchoCath, Inc.): named in the summary without a submission number
- (no number) AccuPlace (Medtronic Interventional Radiology): named in the summary without a submission number

## Indications for use
TargoBeam is an aiming device intended to be used to verify and control correct angulation of interventional devices such as needles used in CT- or MRI-guided punctures, biopsies, and related procedures.

Source page: https://510kreport.com/device/K970819
Methodology: https://510kreport.com/methodology