Colon View, Model CSCV-001A
by Toshibamedical Systems Corporation
510(k) K090220
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090220 | Date11 Feb 2009 | 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- Withdrawn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, 20 Sep 2026
The Colon View, Model CSCV-001A is a computed tomography (CT) system designed for imaging the colon. It falls under the category of X-ray, Tomography, Computed devices and is intended for detailed visualization of the gastrointestinal tract, particularly the colon, to aid in diagnostic evaluations such as detecting abnormalities, polyps, or tumors.
This device is supplied as a reusable medical system and is regulated under FDA 510(k) clearance (K090220) with a traditional review process. It is classified as a Class II device under special controls and was cleared by the FDA on February 11, 2009. The system is intended for use in radiology settings and adheres to standard CT imaging protocols, though specific sterility or MRI safety details are not provided in the available data.
Other devices from Toshiba Medical Systems
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the Colon View, Model CSCV-001A in clinical practice?
The Colon View, Model CSCV-001A is a computed tomography (CT) system specifically designed to provide detailed imaging of the colon. Its main purpose is to aid in diagnostic evaluations, such as identifying abnormalities like polyps or tumors within the gastrointestinal tract, by offering high-resolution visualization of the colon area.
Is the Colon View, Model CSCV-001A intended for single-use or reusable in a clinical setting?
The Colon View, Model CSCV-001A is supplied as a reusable medical system. This means it is designed for repeated use in radiology settings after appropriate cleaning, maintenance, and sterilization procedures as per manufacturer guidelines.
How is the Colon View, Model CSCV-001A regulated by the FDA, and what does that mean for its use?
The Colon View, Model CSCV-001A is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K090220. It was determined to be substantially equivalent to a legally marketed device and was cleared on February 11, 2009. This classification as a Class II device under special controls means it undergoes additional scrutiny to ensure safety and performance, but it does not require the same rigorous review as a Class III device.
Where would this device typically be used, and what type of environment is it designed for?
The Colon View, Model CSCV-001A is intended for use in radiology departments within healthcare facilities. It is designed for clinical settings where CT imaging is performed, adhering to standard protocols for computed tomography scans of the gastrointestinal tract, particularly the colon.
Who is the manufacturer of the Colon View, Model CSCV-001A, and how can I contact them for further information?
The manufacturer of the Colon View, Model CSCV-001A is Toshiba Medical Systems Corporation. For further information, you can contact them through the provided address: 2441 Michelle Dr., Tustin, CA 92780, or reach out to Paul Biggins, who appears to be a point of contact for inquiries.