Vieworks’ Slide Scanner Receives CE IVDR Certification for European Market

SEOUL, south Korea –⁣ Vieworks, a ⁤specialist in medical and industrial video solutions, announced its new slide ⁢scanner has achieved CE IVDR certification, a European diagnostic medical device standard. The ⁣announcement was made June‍ 6.

Visque DPS LH510 Targets Core European Market

The certified product, the ‘Visque⁢ DPS (Digital Pathology System) LH510’, is now positioned to target the European market, a key region for digital pathology diagnostics.

Stringent In Vitro Diagnostic Regulations Met

The Visque⁢ DPS LH510 reportedly passed all requirements under‍ the new European in vitro diagnostic⁣ medical device⁢ regulations implemented in May 2022. These regulations include stricter requirements for technical documentation, clinical performance‍ evaluations, and post-market‍ surveillance.

High-Speed, High-Resolution Digital Pathology

The⁤ VISQUE DPS⁣ is described⁢ as a high-speed digital pathology scanner designed to ⁤reconstruct glass tissue slides into high-resolution⁣ whole slide images ⁣(WSI).It accommodates both tissue and cytology samples, ⁢ensuring rapid scan speeds, high-resolution video quality,⁤ and ease of⁣ maintenance.

Advanced Imaging⁤ Technology

Vieworks utilizes a self-developed high-resolution camera incorporating ‘RealTIME ⁤EXTENDED FOCUS MOD’ technology. This technology⁢ selects and synthesizes vivid areas from⁤ three differently focused images in a single scan. The system can accommodate up to 510 tissue slides,creating 83 WSIs (15x15mm) per hour.

Recognition for Technology and Safety

According to a Vieworks official, the ⁢slide scanner’s certification demonstrates recognition of its “excellent technology and safety for the global ‍market” by meeting the requirements of European in vitro diagnostic medical device standards.

Vieworks Visque DPS LH510 Slide Scanner: Your⁤ Questions ⁤Answered

Are you curious about Vieworks’ new slide ⁣scanner and its recent⁤ regulatory approvals? This Q&A-style article provides a thorough overview of the ⁤Visque DPS LH510 digital pathology system.

What is the Visque DPS LH510?

The Visque DPS LH510 ⁢is a high-speed digital pathology scanner⁢ developed by Vieworks.‍ It’s designed⁣ to transform customary ‍glass tissue slides into high-resolution⁣ whole slide images (WSI).

What is the significance of the CE IVDR certification?

The Visque DPS⁢ LH510 has ‍received CE IVDR certification.This⁣ certification is a European standard for in vitro ‍diagnostic medical devices.This certification indicates that the scanner meets the stringent requirements of European regulations for safety, ⁢performance, and quality. This certification opens the door for Vieworks to market the Visque DPS LH510 in the European market.

What does “CE IVDR” stand for?

CE IVDR stands for “CE, In Vitro⁣ Diagnostic Regulation.” It is the new ‍European Union regulation for in vitro diagnostic medical devices. ‍CE marking indicates ⁤that a product complies with the requirements of the relevant EU directives.

Who is Vieworks?

Vieworks is a specialist company ⁤based in South Korea that concentrates on medical and industrial video solutions.

What⁤ are the ⁤key features⁢ of the visque DPS LH510?

The Visque DPS LH510 is designed for:

high-Speed Scanning: Rapidly scans slides to ⁢create digital images.

High Resolution: Produces high-resolution whole slide images (WSI).

Versatility: Accommodates both tissue and cytology samples.

Advanced Imaging Technology: Employs ‘RealTIME EXTENDED FOCUS MOD’ technology for ‍enhanced image clarity.

High Capacity: the system can⁣ handle ‍up to 510 tissue slides.

What is “RealTIME EXTENDED⁤ FOCUS MOD” technology?

This is ‍a proprietary technology developed by Vieworks. The scanner uses this technology to⁤ capture multiple ‍images at different focal points. it then synthesizes parts of those images with the sharpest ‍focus into a‍ single, high-quality image.

What regulatory standards ⁢did⁤ the Visque DPS LH510 meet?

The scanner‍ complies with the new European in vitro diagnostic medical device regulations⁤ implemented in may 2022. These ⁤regulations impose stricter criteria ⁤for:

⁤ ⁣Technical documentation

Clinical performance evaluations

⁣ Post-market surveillance

What samples can the Visque DPS LH510 scan?

The Visque DPS LH510 can scan:

Tissue samples

⁤ Cytology samples

What are the advantages of using a ⁣digital pathology scanner⁣ like the Visque DPS LH510?

Digital pathology scanners like the Visque DPS LH510 offer many⁤ advantages. They allow for faster⁢ image⁣ acquisition,⁢ easier image sharing, and improved collaboration among pathologists.

How does the Visque DPS LH510 compare to other slide ‍scanners?

Here’s a summary of the Visque DPS ⁤LH510’s key⁣ features from the available text:

Feature	Description
Scanning Speed	High⁣ speed
Resolution	High Resolution WSIs
Sample Types	Tissue and Cytology
Imaging Technology	RealTIME EXTENDED FOCUS MOD
Slide Capacity	Up‍ to ⁢510 slides
WSIs per Hour	83 (15x15mm)

What ⁢does the CE IVDR certification mean for the‍ European market?

It ⁢confirms that the scanner complies with the strict ⁢requirements of EU regulations, allowing it to be marketed and sold in Europe.

What is⁤ the target market for the Visque DPS LH510?

The primary target market⁢ is the European market, which is a key region for digital pathology diagnostics.

Where was the CE IVDR certification declaration made?

The announcement was made in Seoul, South Korea, on june 6.

How does the Vieworks official ⁣describe this ‍approval?

According to a ⁢Vieworks official, the certification highlights the scanner’s “excellent technology and safety for the⁤ global market.”