MINI 6800 DIGITAL MOBILE C-ARM— 510(k) K992506
Substantially EquivalentGe Dec Medical Systems
FDA 510(k) clearance K992506 for MINI 6800 DIGITAL MOBILE C-ARM, Substantially Equivalent on 1999-08-19. Applicant: Ge Dec Medical Systems. Device class: 2.
Clearance details
- Applicant
- Ge Dec Medical Systems
- Product code
- Code OXO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Salt Lake City, UT, US
Recent devices under product code OXO
view allMore clearances from Ge Dec Medical Systems
view allAdverse events under product code OXO
product code OXO- Death
- 6
- Injury
- 163
- Malfunction
- 2,099
- Other
- 1
- Total
- 2,269
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 K992506
K-number listed on FDA's recall record- Z-0974-2017 — OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging
- Z-0193-2015 — OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
- Z-2126-2012 — OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.
- Z-2040-2012 — OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992506.
Data sourced from openFDA. This site is unofficial and independent of the FDA.