Lux 35 Detector— 510(k) K203159
Substantially EquivalentCarestream Health
FDA 510(k) clearance K203159 for Lux 35 Detector, Substantially Equivalent on 2020-12-02. Applicant: Carestream Health. Device class: 2.
Clearance details
- Applicant
- Carestream Health
- 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
- Special
- Location
- Rochester, NY, US
Recent devices under product code MQB
view allMore clearances from Carestream Health
view allData sourced from openFDA. This site is unofficial and independent of the FDA.