Critical Care Suite

Basic Information

• Brand Name: Critical Care Suite
• Primary DI: 00195278789365
• Version / Model: 2.1
• Company Name: GE MEDICAL SYSTEMS, INC.
• Labeler DUNS: 809785715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-19
• Public Version: 1
• Public Version Date: 2023-10-27
• Public Version Status: New
• Public Device Record Key: 3fc3b3b8-a015-4992-877a-09fe30713923

Device Description

Critical Care Suite 2.1, Designated Medical Device

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
QBS	Radiological Computer Assisted Detection/Diagnosis Software For Fracture	Radiology	892.2090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63386	X-ray image interpretive software	An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195278789365	GS1

Premarket Submissions

Submission Number	Supplement Number
K223491	000