NA

Basic Information

• Brand Name: NA
• Primary DI: 04260491560018
• Version / Model: XCT 2000L
• Catalog Number: XCT 2000L
• Company Name: Stratec Medizintechnik GmbH
• Labeler DUNS: 321874737
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b5790fcb-f530-4efd-b3f2-acaf33d2ddc6

Device Description

Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
KGI	Densitometer, Bone	Radiology	892.1170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37619	Limited-view-field CT system	An assembly of diagnostic x-ray computed tomography (CT) devices having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260491560018	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K983273	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 68 – 82.5 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity