Omega Medical Imaging, LLC
Sanford, FL, US
OMEGA MEDICAL IMAGING, LLC appears in FDA device records in Sanford, FL. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Omega Medical Imaging, LLC between 1990 and 2025. The busiest year on record is 2010, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 2 |
| 2012 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242488 | Soteria E-View | JAA | Substantially Equivalent | |
| K212890 | Nyquist.IQ | JAA | Substantially Equivalent | |
| K212336 | Soteria.AI | OWB | Substantially Equivalent | |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) | JAA | Substantially Equivalent | |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | JAA | Substantially Equivalent | |
| K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System | OWB | Substantially Equivalent | |
| K121293 | CS-SERIES-FP WITH 3030+OPTION | JAA | Substantially Equivalent | |
| K100102 | CS-SERIES-FP | OWB | Substantially Equivalent | |
| K093572 | R650 QDASM COLLIMATOR | IZW | Substantially Equivalent | |
| K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) | OWB | Substantially Equivalent | |
| K062647 | E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 | OWB | Substantially Equivalent | |
| K050092 | R605 FACS COLLIMETER | IZW | Substantially Equivalent | |
| K990055 | B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 | JAA | Substantially Equivalent | |
| K970947 | B-350 CEILING MOUNTED C-POSITIONER | JAA | Substantially Equivalent | |
| K902005 | MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE | JAA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1052701 | 1000222289 | OMEGA MEDICAL IMAGING, LLC | 3400 St. Johns Parkway, Suite 1020, Sanford, FL 32771 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0160-2024 | Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 | An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable. | Class II | Open, Classified | |
| Z-0156-2024 | Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 | An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location. | Class II | Open, Classified | |
| Z-2621-2017 | Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals. | Elevating Monitor Suspension column dropping and will not rise back up. | Class II | Terminated | |
| Z-2734-2016 | 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems. | Elevating Monitor Suspension separated from the lifting column bracket | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain