Monitor, Patient Position, Light-Beam
Regulation 892.5780
0510(k)s in 12 months (28 all time)
1recalls in 12 months (8 all time)
1recalls that name a 510(k)
Top companies in IWE
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtec, Inc. | 7 | 0 |
| Diacor, Inc. | 4 | 0 |
| A2j, Inc. | 3 | 0 |
| Cp Bio-Medical Corp. | 3 | 0 |
| GE Healthcare | 0 | 3 |
| Omega Medical Imaging, Inc. | 0 | 3 |
| Medical Alignment Systems | 2 | 0 |
| Advantage Medical Systems, Inc. | 1 | 0 |
| Atc Medical Technology, Inc. | 1 | 0 |
| Gammex, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2026 | Vision RT Ltd The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. Open, Classified |
IWE | None listed |
| Oct 24, 2023 | Omega Medical Imaging, Inc. Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 Open, Classified |
IWE | None listed |
| Oct 24, 2023 | Omega Medical Imaging, Inc. Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 Open, Classified |
IWE | None listed |
| Jun 19, 2017 | Omega Medical Imaging, Inc. Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory
Device accessory that elevates monitor for healthcare professionals. Terminated |
IWE | None listed |
| May 1, 2015 | GE Healthcare GE Discovery MR950 MRI system Terminated |
IWE | None listed |
| Feb 8, 2012 | GE Healthcare, LLC GE Healthcare Signa, Discovery and Optima.
Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T Infinity TwinSpeed, Signa Lx; Signa Infinity MR System with EXCITE Technology, Excite II, Signa Exc Terminated |
IWE | None listed |
| Jul 21, 2011 | GE Healthcare, LLC GE Healthcare DISCOVERY MODEL NM/CT 670
NM/CT system Terminated |
IWE | None listed |
| May 4, 2010 | Hitachi Medical Systems America Inc Hitachi Oasis Magnetic Resonance Scanners Software V1.0C
The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal s Terminated |
IWE | K072279 |
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