UROVIEW 2800— 510(k) K993687
Substantially EquivalentGe Dec Medical Systems
FDA 510(k) clearance K993687 for UROVIEW 2800, Substantially Equivalent on 1999-12-21. Applicant: Ge Dec Medical Systems. Device class: 2.
Clearance details
- Applicant
- Ge Dec Medical Systems
- Product code
- Code OWB
- 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 OWB
view allMore clearances from Ge Dec Medical Systems
view all- K000221 — SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
- K992506 — MINI 6800 DIGITAL MOBILE C-ARM
- K974355 — INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
- K970063 — SERIES 7600 MOBILE DIGITAL C-ARM
- K963952 — SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 K993687
K-number listed on FDA's recall record- Z-2628-2016 — OEC UroView 2800, fluoroscopic x-ray system
- Z-2629-2016 — OEC 9800, fluoroscopic x-ray system
- Z-0192-2015 — OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
- Z-2127-2012 — UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion.
- Z-1865-2012 — OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993687.
Data sourced from openFDA. This site is unofficial and independent of the FDA.