DeltaScan 2000 Series
510(k) K771082
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771082 | Date24 Jun 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The DeltaScan 2000 Series is a computed tomography (CT) system designed for medical imaging, specifically within the radiology specialty. As a Class II X-ray tomography device, it generates cross-sectional images of the body using computed radiography techniques to aid in diagnostic evaluations. This system falls under the regulatory classification of a system for X-ray tomography, enabling detailed visualization of internal structures.
This device is intended for use in radiology departments and clinical settings where computed tomography imaging is required. Supplied as a reusable medical system, it operates under regulatory oversight as a substantially equivalent (SESE) device under FDA 510(k) clearance (K771082). The DeltaScan 2000 Series adheres to the standards outlined in regulation 892.1750, ensuring compliance with safety and performance requirements for computed tomography systems. No specific sterility or single-use designation is noted in the regulatory filings.