TABLE, X-RAY, RFX CLASSICAL— 510(k) K760466
Substantially EquivalentGeneral Electric Co.
FDA 510(k) clearance K760466 for TABLE, X-RAY, RFX CLASSICAL, Substantially Equivalent on 1976-08-26. Applicant: General Electric Co.. Device class: 2.
Clearance details
- Applicant
- General Electric Co.
- Product code
- Code IXR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1980
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code IXR
view allMore clearances from General Electric Co.
view allRecalls naming K760466
K-number listed on FDA's recall record- Z-2179-2017 — Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
- Z-0915-2017 — RFX
- Z-0012-2014 — GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects 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 K760466.
Data sourced from openFDA. This site is unofficial and independent of the FDA.