DirectPath
by Cybernet Systems Co., Ltd. 510(k)
Active
510(k) K121449
Overview
DirectPath is a Class II X-ray system used in radiology. It is designed to display the pathway to and virtual bronchoscopic images of a target area, such as a suspicious tumor.
The device received FDA 510(k) clearance (K121449) on July 10, 2012, and is substantially equivalent to a predicate device. It is manufactured by Cybernet Systems Co., Ltd. and is intended for use in radiology settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121449 | Date10 Jul 2012 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the DirectPath X-ray system used for?
DirectPath is designed to display the pathway to and virtual bronchoscopic images of a target area, such as a suspicious tumor, in radiology settings. This helps clinicians visualize and navigate toward specific anatomical targets during diagnostic procedures.
Who manufactures the DirectPath system and where is it based?
The DirectPath system is manufactured by Cybernet Systems Co., Ltd., which is headquartered at 611 W. 5th St., Austin, TX 78701, United States. The company served as the applicant for the FDA 510(k) submission.
When did DirectPath receive FDA clearance and what was the submission number?
DirectPath received FDA 510(k) clearance on July 10, 2012, under submission number K121449. The clearance was granted as substantially equivalent to a predicate device through a traditional review process.