FDA.report

510(k) K001510

Device
OS-2000 OPTICAL SONOGRAPHY SYSTEM
Applicant
ADVANCED DIAGNOSTICS, INC.
510(k) number
K001510
Product code
NCS  
Decision
Substantially Equivalent (SESE)
Decision date
2000-11-30
Date received
2000-05-15
Regulation
892.1550
Classification name
System, Imaging, Holography, Acoustic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
STEVE HESLER
Address
2400 Stevens Dr., Suite C Richland WA US 98126 98126

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code NCS  

510(k)DeviceApplicantDecision date
K013886AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)Advanced Diagnostics, Inc.2002-05-10
K013291ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)Advanced Diagnostics, Inc.2001-11-14

Legacy Summary

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FDA Review

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