LEGACY/LEGACY-D TABLE— 510(k) K973039
Substantially EquivalentGE Medical Systems
FDA 510(k) clearance K973039 for LEGACY/LEGACY-D TABLE, Substantially Equivalent on 1997-10-16. Applicant: GE Medical Systems. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems
- 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
- Milwaukee, WI, US
Recent devices under product code IXR
view allMore clearances from GE Medical Systems
view allRecalls naming K973039
K-number listed on FDA's recall record- Z-2179-2017 — Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
- Z-1966-2015 — GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
- 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 K973039.
Data sourced from openFDA. This site is unofficial and independent of the FDA.