Carestream DRX-1 System with DRX Plus 4343 Detectors— 510(k) K153142
Substantially EquivalentCarestream Health, Inc.
FDA 510(k) clearance K153142 for Carestream DRX-1 System with DRX Plus 4343 Detectors, Substantially Equivalent on 2015-11-25. Applicant: Carestream Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Carestream Health, Inc.
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code MQB
view allMore clearances from Carestream Health, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.