3D Accuitomo XYZ Slice View Tomograph

Basic Information

• Brand Name: 3D Accuitomo XYZ Slice View Tomograph
• Primary DI: 04548213016341
• Version / Model: MCT-1
• Company Name: J.MORITA MFG.CORP.
• Labeler DUNS: 693811465
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-21
• Public Version: 1
• Public Version Date: 2020-03-30
• Public Version Status: New
• Public Device Record Key: 9ee4e6ac-c590-4918-8377-3f5a6ca50532

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61019	Cone beam computed tomography system, head/neck	A stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04548213016341	GS1

Premarket Submissions

Submission Number	Supplement Number
K073695	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 8 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -5 – 43 Degrees Celsius