AeroDR 0170CS

Basic Information

• Brand Name: AeroDR 0170CS
• Primary DI: 04560141946262
• Version / Model: AACW
• Company Name: KONICA MINOLTA, INC.
• Labeler DUNS: 692076161
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-26
• Public Version: 4
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 7a11194c-9341-4beb-8edd-eb9b32abde36

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
KPR	System, X-Ray, Stationary	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40946	X-ray system tube support, ceiling mounted	A component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be mounted on the ceiling to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls. The x-ray tube assembly is attached to the rack and can be moved along the rack and/or tilted. Some designs also support the movement and positioning of an image receptor assembly (e.g., C-arm assembly).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560141946262	GS1

Premarket Submissions

Submission Number	Supplement Number
K121109	000