# K202084: DeepLook PRECISE

- Pathway: 510(k) (Traditional)
- Applicant: Deeplook, Inc.
- Decided: Apr 9, 2021 after 256 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191530: StoneChecker, Imaging Biometrics, LLC (2019) Summary page 4.

## Indications for use
DeepLook PRECISE is a software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) that is identified by the user in DICOM images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can optionally provide a colorization of the interior area defined by a margin. DeepLook PRECISE does not make clinical decisions nor is a decision-support tool. The information provided by the software is an initial estimate and must not be used in isolation when making patient management decisions. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA cleared monitor that offers at least 5 Mega-pixel resolutions and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained physicians and radiologists. DeepLook PRECISE, is not intended for use on mobile devices.

Source page: https://510kreport.com/device/K202084
Methodology: https://510kreport.com/methodology