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510(k) K944772

Device
MULTIPLE ED1600 SERIES RADIATION SHIELDS
Applicant
IMAGE DIAGNOSTICS, INC.
510(k) number
K944772
Product code
EAK  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-20
Date received
1994-09-27
Regulation
892.6500
Classification name
Screen, Leaded, Operator Radiation Protector
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
REMO J ROSSI
Address
98 Pratts Junction Rd. Sterling MA US 01564 01564

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EAK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952233CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628Victoreen, Inc.1995-06-16
K944445ED CORP RADIATION SCREENMed Corp.1995-05-11
K896949MOBILE X-RAY PERSONNEL PROTECTIVE SCREENSInnovative Products Mfg.1990-02-16
K861019CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELDPhase One Disign Co.1986-04-02
K850814MODULAR X-RAY BARRIERSVictoreen, Inc.1985-04-10
K850816LEAD PLASTIC VIEWING PANELSVictoreen, Inc.1985-04-10

Legacy Summary#

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FDA Review#

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