A broad range of devices...
- Diagnostic imaging devices and
accessories (e.g., MRI and ultrasound)
- Lasers
- PACS (Picture Archiving and
Communications Systems)
- Interventional radiology
- Steam sterilizers
- Bone densitometry
- Minimally-invasive surgical devices
- Infra-red digital thermometers (OTC)
- Initial reports for laser products
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Global clients...
- Erlangen, Germany
- Hong Kong, China
- Independence, OH
- Paris, France
- Santa Clara, CA
- Seoul, South Korea
- Singapore
- Tel Aviv, Israel
- Torrance, CA
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Track record...
- Over 70 510(k) submissions successfully submitted to FDA for review and clearance
- 2003 First 3.0T MRI-compatible oxygen cylinder
- K033897 (FDA website) >>>
510(k) Summary (Size: 180k) >>>
- 2002 First infrared OTC digital forehead thermometer
- K020433 (FDA website) >>>
510(k) Summary (Size: 252k) >>>
- 1998 First electronic device submission to FDA
- K982157 (FDA website) >>>
510(k) Summary (Size: 244k) >>>
- 1995 First laparoscopic ultrasound system and transducers
- K945796 (FDA website) >>>
510(k) Summary (Size: 264k) >>>
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