Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡บ๐Ÿ‡ธ United States

Intuition

TeraRecon, Inc. ยท ๐Ÿ‡บ๐Ÿ‡ธ United States
Devices (same UDI-DI)
1
Certificates
1
Countries
19
Notified Bodies
1

Basic Information

Primary DI
INTUITION04
Basic UDI-DI Code
B-INTUITION04
Reference
Intuition
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
TeraRecon, Inc.

Additional Description

Intuition is a medical device comprised of two stand-alone software components: a server software backend (Intuition Server) which performs complex image post processing and client viewer software (Intuition Client Viewers) that provides a user interface, enabling the user to view medical image data and associated derived metadata. The Intuition client viewer/server software enables 2D/3D/4D (3D with the dimension of time) image review, volume rendering, communications, storage, reporting, and image post processing. The Intuition software is used with off-the-shelf hardware, including a computer, monitor, keyboard and mouse. Intuition is comprised of six (6) separate client viewers: Intuition Client, Intuition Thin Client, Intuition Review, Intuition EMV, Intuition Web Viewer, and Intuition Mobile.

CND Nomenclature Codes

Code Description
Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Certificates

Type Number
MDD Annex II (excluding section 4) HD 60146453 0001

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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