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510(k) K925705

Device
ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM
Applicant
DENAR CORP.
510(k) number
K925705
Product code
IWY  
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-28
Date received
1992-11-12
Regulation
892.1920
Classification name
Holder, Head, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS J MULDOON
Address
333 W. Wacker Dr. Suite 2600 Chicago IL US 60606 60606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884493HEAD HOLDING DEVICE/SLEEP APNEAX-Ray Systems1989-01-12
K884847MTD HEDRESTComposites Horizons, Inc.1989-01-09
K864527DUOCEPHGary E. Hall, Dds1987-01-07
K850197KELLER CEPHALOMETRIC DEVICEGary D. Keller1985-03-22
K844549HEAD-SPINE STABILIZER HSS-1Imaging Accessories, Inc.1985-03-01
K843340PORTA-STATPorta-Stat, Inc.1984-11-27
K834559DELUXE WALL-MOUNTED CEPHALOMETERKnochen Dental Laboratory1984-02-21
K802140LEKSELL STEREOTACTIC SYSTEMDowns Surgical , Ltd.1981-02-05
K772313X-RAY CO-ORDINATORRinn Corp.1978-01-30

Legacy Summary#

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FDA Review#

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