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510(k) K013291

Device
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
Applicant
ADVANCED DIAGNOSTICS, INC.
510(k) number
K013291
Product code
NCS  
Decision
Substantially Equivalent (SESE)
Decision date
2001-11-14
Date received
2001-10-02
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
8112 304th Ave. Se. Preston WA US 98050 98050

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
K001510OS-2000 OPTICAL SONOGRAPHY SYSTEMAdvanced Diagnostics, Inc.2000-11-30

Legacy Summary

summary

FDA Review

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