3D Accuitomo XYZ Slice View Tomograph

GUDID 04548213018611

J.MORITA MFG.CORP.

Cone beam computed tomography system, head/neck
Primary Device ID04548213018611
NIH Device Record Keydec5fe13-9878-4e11-95c6-60fd6190eac6
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D Accuitomo XYZ Slice View Tomograph
Version Model NumberMCT-1
Company DUNS693811465
Company NameJ.MORITA MFG.CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -5 Degrees Celsius and 43 Degrees Celsius
Storage Environment HumidityBetween 8 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104548213018611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-27

On-Brand Devices [3D Accuitomo XYZ Slice View Tomograph]

04548213025046MCT-1
04548213018611MCT-1
04548213016341MCT-1

Trademark Results [3D Accuitomo XYZ Slice View Tomograph]

Mark Image

Registration | Serial
Company
Trademark
Application Date
3D ACCUITOMO XYZ SLICE VIEW TOMOGRAPH
3D ACCUITOMO XYZ SLICE VIEW TOMOGRAPH
78171691 2893874 Live/Registered
J. MORITA MFG. CORP.
2002-10-07

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