AccessGUDID - DEVICE: Incisive CT (00884838105508)

GUDID

Device Identifier (DI) Information

Brand Name: Incisive CT
Version or Model: 728144
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 728144
Company Name: Philips Healthcare (Suzhou) Co., Ltd.

Primary DI Number: 00884838105508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 421265537 *Terms of Use

Device Description: The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37618	Full-body CT system	An assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with 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 special 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -15 and 45 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b9df3797-2904-46c8-a240-9e8f01869ef8
Public Version Date: October 28, 2024
Public Version Number: 4
DI Record Publish Date: December 30, 2021