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

Oasis

Segami Corporation ยท ๐Ÿ‡บ๐Ÿ‡ธ United States
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1

Basic Information

Primary DI
00857198006006
Basic UDI-DI Code
B-00857198006006
Reference
1.9.4.12
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
Segami Corporation

Additional Description

Oasis is an advanced visualization, quantification, and reporting software solution for nuclear medicine diagnostic imaging. It integrates multiple modalities โ€” SPECT, PET, CT, and MRI โ€” for the accurate interpretation of organ function and anatomy in a single, comprehensive environment. The intuitive, user-centered environment guides the user while providing configurable preferences for workflow personalization. The core functionality is to provide an accurate environment for quantification and display of nuclear medicine images and other related modalities. It supports a wide variety of study types, based on European and North American published standards and guidelines. Oasis provides a non-manufacturer specific solution for review of images from a wide variety of available scintigraphic cameras. Data may be passed to Oasis either from a connected or integrated Oasis server/database or from various commercially available PACS system databases. The system is intended for use in imaging centers and hospitals by qualified nuclear medicine personnel trained in the use of the Oasis product.

CND Nomenclature Codes

Code Description
Z11029092 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE

Certificates

Type Number
MDD Annex II (excluding section 4) US19/819943515

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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