LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM— 510(k) K121838
Substantially EquivalentLiebel-Flarsheim
FDA 510(k) clearance K121838 for LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM, Substantially Equivalent on 2012-07-11. Applicant: Liebel-Flarsheim. Device class: 2.
Clearance details
- Applicant
- Liebel-Flarsheim
- 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
- Cincinnati, OH, US
Recent devices under product code MQB
view allRecalls naming K121838
K-number listed on FDA's recall record- Z-1992-2021 — HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
- Z-2834-2018 — Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121838.
Data sourced from openFDA. This site is unofficial and independent of the FDA.