Planar Dome EX Line Model Dome E2C
510(k) K061018
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061018 | Date28 Apr 2006 | 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- Withdrawn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
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Planar Dome EX Line Model Dome E2C is a color medical imaging display classified under the product code LLZ, designed for radiology applications. It functions as a high-resolution flat-panel display intended for the review, analysis, and diagnostic interpretation of digital medical images by trained medical professionals. This device falls under the category of radiological imaging equipment, specifically for visualizing X-ray and other radiographic studies. Its dome enclosure protects the display from environmental contaminants while maintaining optimal viewing conditions.
This device is supplied as a reusable, non-sterile medical imaging display intended for use in radiology departments and diagnostic imaging centers. It is not MRI-safe and must be positioned outside the MRI scanning room or area. The Planar Dome EX Line Model Dome E2C is cleared by the FDA under 510(k) clearance (K061018) and is intended for professional medical use only. Storage and handling should follow manufacturer guidelines to ensure display integrity and longevity.
Other devices from Planar Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Planar Dome E2C designed for?
The Planar Dome E2C is a high-resolution flat-panel display specifically designed for radiology applications. It is intended for the review, analysis, and diagnostic interpretation of digital medical images, such as X-rays and radiographic studies, by trained medical professionals. Its dome enclosure protects the display from environmental contaminants while ensuring optimal viewing conditions.
Is the Planar Dome E2C reusable or single-use?
The Planar Dome E2C is supplied as a reusable medical imaging display. It is not intended for single-use and is meant to be used repeatedly in radiology departments and diagnostic imaging centers, provided it is maintained and handled according to manufacturer guidelines.
Is the Planar Dome E2C sterile?
No, the Planar Dome E2C is non-sterile. It is designed for professional medical use in controlled environments like radiology departments, where sterility is not required for the display itself but rather for the imaging studies being reviewed.
Can the Planar Dome E2C be used in an MRI room?
No, the Planar Dome E2C is not MRI-safe. It must be positioned outside the MRI scanning room or area to avoid interference or safety risks associated with magnetic resonance imaging environments.
What regulatory clearance does the Planar Dome E2C have?
The Planar Dome E2C is cleared by the FDA under a 510(k) clearance with the reference number K061018. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and is intended for professional medical use only.