Organization name

Segami Corporation

SRN

US-MF-000002014

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  The system is intended for use in imaging centers and hospitals by qualified nuclear medicine personnel trained in the use of the Oasis product.

Primary placement in France; available across 32 countries total.

Trade name

Oasis

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00857198006006

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-00857198006006

Reference / catalog number

1.9.4.12

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Oasis is an advanced visualization, quantification, and reporting software solution for nuclear medicine diagnostic imaging. It integrates multiple modalities — SPECT, PET, CT, and MRI — 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.

Additional information URL

https://www.segamicorp.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z11029092VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.