# K233634: TeleScan

- Pathway: 510(k) (Traditional)
- Applicant: Bb Imaging
- Decided: Dec 12, 2023 after 29 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 K954874 (1996). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220767: TeleScan, Bb Imaging (2022) Summary page 4.

## Indications for use
TeleScan® is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data. Images and data can be stored, communicated, and displayed within the system or across computer systems. TeleScan® provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis. TeleScan® is used by appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians, in a medical facility. TeleScan® may provide information to be used for diagnostic procedures. TeleScan® allows remote qualified radiologists and clinicians to provide a diagnosis remotely.

Source page: https://510kreport.com/device/K233634
Methodology: https://510kreport.com/methodology