FDA.reportPublic FDA data

510(k) K920962

Device
Multiple Accessory To Gamma Cameras
Applicant
NU AGE PRODUCTS
510(k) number
K920962
Product code
IYZ
Decision
Substantially Equivalent (SESE)
Decision date
1992-04-17
Date received
1992-02-03
Regulation
892.1350
Classification name
Bed, Scanning, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Address
2271-F Palmdale Blvd., Suite B-38 Palmdale CA US 93550 93550

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IYZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K915541SPECT TABLE, MODEL #056-760Atomic Products Corp.1992-01-17
K911691XYZ CRANK IMAGING TABLEMed-Tron Products, Inc.1991-08-09
K912286CARDIAC SPECT PALLETSiemens Gammasonics, Inc.1991-08-02
K912481ECT CARBON FIBER PALLET, MODIFICATIONSiemens Gammasonics, Inc.1991-08-02
K912135XY IMAGING TABLEMed-Tron Products, Inc.1991-07-17
K912181E-Z LIFT CRANK IMAGING TABLEMed-Tron Products, Inc.1991-07-17
K911561XYZ IMAGING TABLE WITH FOOT PUMPMed-Tron Products, Inc.1991-07-15
K911564E-Z LIFT IMAGING TABLE WITH FOOT PUMPMed-Tron Products, Inc.1991-07-15
K903901SCANNING COTMed-Tron Products, Inc.1990-09-21
K903767ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PALSiemens Gammasonics, Inc.1990-09-07
K893826QRSYSTEMS H.D. NUCLEAR IMAGING TABLEQrsystems, Inc.1989-08-02