PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD— 510(k) K943805
Substantially EquivalentGeneral Electric Co.
FDA 510(k) clearance K943805 for PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD, Substantially Equivalent on 1994-09-23. Applicant: General Electric Co.. Device class: 2.
Clearance details
- Applicant
- General Electric Co.
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
Recent devices under product code JAA
view allMore clearances from General Electric Co.
view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K943805
K-number listed on FDA's recall record- Z-1751-2019 — Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
- Z-0911-2017 — Prestige II
- Z-0912-2017 — Prestige SI
- Z-0913-2017 — Prestige VH
- Z-0804-2014 — Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K943805.
Data sourced from openFDA. This site is unofficial and independent of the FDA.