Clinix-R Tomographic Device
by Philips Medical Systems (Cleveland), Inc. 510(k)
Active
510(k) K810274
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810274 | Date11 Mar 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- IZF
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1740
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Clinix-R Tomographic Device is a Class II X-Ray Tomographic System, designed for tomographic imaging in radiology. It provides cross-sectional imaging capabilities, enabling detailed visualization of internal structures for diagnostic purposes.
This device is intended for use in radiology settings and was cleared under FDA 510(k) with K-number K810274 in 1981. It is a reusable medical device, regulated under the Federal Register regulation number 892.1740, and falls under the product code IZF. Multiple registration numbers (e.g., 3001722928, 3027605321) are associated with its compliance and tracking.
Other devices from Philips Medical Systems (Cleveland), Inc.
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Questions
AI-generated answers, 19 Sep 2026
What type of imaging does the Clinix-R Tomographic Device provide, and where is it typically used?
The Clinix-R Tomographic Device is an X-Ray Tomographic System designed for cross-sectional imaging, allowing detailed visualization of internal anatomical structures. It is specifically intended for use in radiology settings to aid in diagnostic evaluations.
Is the Clinix-R Tomographic Device single-use or reusable, and how does this affect its maintenance?
The Clinix-R Tomographic Device is a reusable medical device, meaning it is built for repeated use in clinical settings. This design requires proper cleaning, sterilization, and maintenance protocols to ensure consistent performance and compliance with regulatory standards.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?
The Clinix-R Tomographic Device was cleared under the FDA’s 510(k) pathway with K-number K810274 in 1981, following a traditional review process. This means it was determined to be substantially equivalent to a legally marketed device already on the market, allowing it to be used in radiology for cross-sectional imaging under FDA oversight.
How many registration numbers are associated with this device, and what purpose do they serve?
The Clinix-R Tomographic Device has multiple registration numbers (e.g., 3001722928, 3027605321) linked to its compliance and tracking requirements. These identifiers are used for regulatory tracking, reporting, and ensuring traceability of the device in accordance with FDA regulations.
What is the primary medical specialty this device supports, and how does that influence its clinical application?
The Clinix-R Tomographic Device is categorized under the medical specialty of Radiology, meaning it is primarily used by radiologists and radiology technicians. Its cross-sectional imaging capabilities are tailored to support diagnostic evaluations in this specialty, such as identifying abnormalities in internal structures.