# K230871: Extron 5; Extron 7

- Pathway: 510(k) (Traditional)
- Applicant: DRTECH Corporation
- Decided: Aug 17, 2023 after 140 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K042646 (2004). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142708: Veradius Unity, Philips Medical Systems Nethrlands BV (2014) Summary page 5.

## Most influential descendants
- K250010: Extron 3; Extron 5; Extron 7 (2025), 1 descendant of its own
- K261413: Extron 3;Extron 6 (2026), 0 descendants of its own
- K251893: Skan C Pulsar (2025), 0 descendants of its own

## Indications for use
EXTRON5 and EXTRON 7 are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine (※ This device is not intended for mammography applications.)

Source page: https://510kreport.com/device/K230871
Methodology: https://510kreport.com/methodology