Devices

CARESTREAM DIRECTVIEW CR

Model / Serial
Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US distribution to states of : NY, OH, and NC; and countries of: Argentina, Brazil, China, Chile, Colombia, France, Greece, Hong Kong, India, Japan, Korea, Mexico, Peru, Spain, Taiwan, and Thailand.
Product Description
CARESTREAM DIRECTVIEW CR Software || Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Manufacturer
Carestream Health, Inc.
1 Event
- Recall of CARESTREAM DIRECTVIEW CR

Manufacturer

Carestream Health, Inc.

Manufacturer Address
Carestream Health, Inc., 1049 W Ridge Rd, Rochester NY 14615-2731
Manufacturer Parent Company (2017)
ONEX Corp
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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