V2.5.5

Organization name

ALLISONE TECHNOLOGIES

SRN

FR-MF-000020951

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• CW999

  Dental radiographs of patients under 16 years old
• CW999

  Dental radiographs involving primary teeth
• CW999

  Dental intraoral radiographs involving impacted teeth
• CW999

  Dental radiographs that are not intraoral (bitewings, periapical) or panoramic
• CW999

  Dental radiographs that do not have a recognized image format
• CW010

  Consult the electronic instruction for use
• CW999

  Browsers other than Google Chrome cannot be used

Primary placement in France; available across 12 countries total.

Trade name

not provided

UDI-DI code

03770024648065

Basic UDI-DI

3770024648ALSN0019R

Reference / catalog number

V2.5.5

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

computer-assisted detection software device intended to be used by dentists in the review of panoramic, bitewing, and periapical radiographs. It aids dentists in identifying and highlighting regions of interest associated with suspected pathologies, including decays , periapical lesions, and calculus.

Additional information URL

https://app.allisone.ai/

Clinical sizes

No clinical sizes registered for this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

This device is not currently linked to any other device.

Certificate health across this manufacturer's portfolio.