Intended Use

Intended Use

D-Scope Systems Products are FDA Class 1 Medical Devices

To be used by a licensed medical professional

Current version (6.0.1.5)

D-Scope Workstation

Sec. 892.2010 Medical image storage device

Intended Use:

The D-Scope Workstation is a turn-key solution for recording still images, video and audio of procedures.

• Connect to any SD or HD medical camera
• Easily capture video and still images with hands-free controls, without interruption of live video
• Instantly access recording for review with patients
• Make a side-by-side comparison of up to 12 videos/images simultaneously
• Configure for multiple users, each with unique profiles for customized reports and workflows
• Export with one-click to CD/DVD and flash drives
• Import external media from other sources, such as media on a

CD/DVD or DICOM radiology files from a PACS

Notes:

1. The D-Scope Clinic Workstation is intended for recording, storage and retrieval of both image and audio files.
2. There is no technical capability for functions to provide performing operations related to image manipulation, enhancement, compression or quantification.
3. Within the scope of #2 above the term “compression” is meant to manipulate the image or audio to create an “enhancement” or allow “quantification” of the image or audio. D-Scope Clinic Workstation does provide FILE SIZE COMPRESSION which provides for efficient electronic file storage only.

D-Scope OR Workstation

Sec. 892.2010 Medical image storage device

D-Scope Operating Room Media Archive System makes video recording a seamless part of your workflow allowing the physician to record, review, tag and edit from one simple, easy-to-use interface.

Intelligent Tagging & Review

• Tag in real-time during a procedure
• Tag important frames with keywords, comments, and thumbnails
• Jump to sections of a video by clicking on tags or thumbnails
• Instant review of recordings
• Easy edit and merge functions for presentation prep
• Save in multiple formats and resolutions

4. The D-Scope OR Workstation is intended for recording, storage and retrieval of both image and audio files.

5. Notes 1, 2, 3 above apply to the OR Workstation.

6. The “edit” and “merge” functions are to allow for “tag/thumbnail notations” and “merge” is to allow for presentation viewing. Both “edit”and “merge” do not provide for enhancement” or allow “quantification” of the image or audio.

D-Scope Server

Sec. 892.2020 Medical image communications device

The D-Scope Server enables multiple D-Scope Workstations to be networked to a central repository, providing access to all media from any system.

D-Scope Workstation (Software Only)

Sec. 880.6310 Medical device data system.

VIA is a device that is intended to provide the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. The system does not include devices intended to be used in connection with active patient monitoring.

FDA ProCode: OUG