# K170250: SmartTarget

- Pathway: 510(k) (Traditional)
- Applicant: Smarttarget, Ltd.
- Decided: Jun 7, 2017 after 131 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954678 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153073: UroNav (Version 2.0), Invivo Corporation (2015) Summary page 4.

## Recalls of this device
- Dec 23, 2025 · Class II · Z-1243-2026: Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patien

## Indications for use
The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland, and to be used by physicians for enhanced visualization of two-dimensional (2D) transrectal ultrasound TRUS images of the prostate in clinic and hospital settings. It allows the user to segment medical images and it performs three-dimensional (3D) reconstruction of digitized TRUS video images to form a 3D TRUS volume. The SmartTarget software provides 2D and 3D image visualization features, including the ability to review images, generate multi-planar views, annotate images, and identify and record the locations of instruments inserted during the procedure. The device is intended to be used in diagnostic and treatment procedures in a clinical setting in which a needle or other instrument is inserted into the prostate through the perineum or urethra, or instruments that are positioned externally to the prostate so that treatment can be delivered to prostate tissue, or diagnostic information obtained from prostate tissue. Example procedures include, but are not limited to: needle biopsy in which tissue samples are removed from the prostate; in situ diagnostic techniques, such as those based on optical sensing; thermal tissue ablation using radiofrequency, microwave, laser, cryotherapy, or high-intensity focused ultrasound; photodynamic therapy; irreversible electroporation; radioactive source implantation (brachytherapy); and locally-injected drug therapies

Source page: https://510kreport.com/device/K170250
Methodology: https://510kreport.com/methodology