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

Applicant Contact#

Contact: STEVE HESLER
Address: 8112 304th Ave. Se. Preston WA US 98050 98050

Source Documents#

Other 510(k) Records For Product Code NCS #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K013886	AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)	Advanced Diagnostics, Inc.	2002-05-10
K001510	OS-2000 OPTICAL SONOGRAPHY SYSTEM	Advanced Diagnostics, Inc.	2000-11-30

Legacy Summary#

summary

FDA Review#

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