Carestream DRX-1 System with DRX Core Detectors
K-Number: K183474 · 2019-01-16
Device Summary
Frequently Asked Questions
What is the Carestream DRX-1 System with DRX Core Detectors?
Carestream DRX-1 System with DRX Core Detectors is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Carestream Health, Inc.. The 510(k) number is K183474.
When did Carestream DRX-1 System with DRX Core Detectors receive FDA 510(k) clearance?
Carestream DRX-1 System with DRX Core Detectors received FDA 510(k) clearance on 2019-01-16, under 510(k) number K183474.
Who is the listed applicant for Carestream DRX-1 System with DRX Core Detectors?
The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Carestream DRX-1 System with DRX Core Detectors?
The FDA product code for Carestream DRX-1 System with DRX Core Detectors is MQB.
Other records listing Carestream Health, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MQB)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.