CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR— 510(k) K130464
Substantially EquivalentCarestream Health, Inc.
FDA 510(k) clearance K130464 for CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR, Substantially Equivalent on 2013-06-07. 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
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