CARESTREAM DRX-1 SYSTEM— 510(k) K090318
Substantially EquivalentCarestream Health, Inc.
FDA 510(k) clearance K090318 for CARESTREAM DRX-1 SYSTEM, Substantially Equivalent on 2009-04-06. 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 allRecalls naming K090318
K-number listed on FDA's recall record- Z-0180-2014 — CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
- Z-2202-2012 — Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090318.
Data sourced from openFDA. This site is unofficial and independent of the FDA.