DEVICE: ACTEON (M430S71715041)
Device Identifier (DI) Information
ACTEON
DOCK U USB ADEC 300 7M GR3
In Commercial Distribution
S_717_1504
SOPRO
DOCK U USB ADEC 300 7M GR3
In Commercial Distribution
S_717_1504
SOPRO
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This
product is designed for dental applications and is not intended for diagnosis."
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35580 | Diagnostic-imaging multiformat camera |
An electrically-powered camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NYH | Plaque Disclosing Kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d34b1c1d-b1c8-4897-89ed-1ffb0444d019
December 04, 2020
3
September 24, 2016
December 04, 2020
3
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+33556340607
info@acteongroup.com
info@acteongroup.com