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510(k) K853756

Device
DYNAMIC CARDIAC PHANTOM 74-347
Applicant
VICTOREEN, INC.
510(k) number
K853756
Product code
IXY  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-29
Date received
1985-09-09
Regulation
892.1880
Classification name
Holder, Radiographic Cassette, Wall-mounted
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GLASSER
Address
100 Voice Rd. Carle Place NY US 11514 11514

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IXY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953402UNIVERSIX 190Philips Medical Systems (Cleveland), Inc.1995-08-11
K953336VRS 3 WALL STANDPhilips Medical Systems (Cleveland), Inc.1995-08-11
K946114SENSORI-MOTOR RATING SCALECmed1995-04-28
K946260NTBS-1417, 1436, TBS-1417Scott Imaging Intl., Inc.1995-03-31
K930249BC/WT/PFTingle X-Ray Products, Inc.1993-04-27
K930230RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDERAmerican Medical Sales, Inc.1993-04-27
K925934WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNTContinental X-Ray Corp.1993-03-04
K924445BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKYControl-X, Inc.1993-02-19
K922443VERT-X UNIVERSAL VERTICAL BUCKY STANDAfp Imaging Corp.1992-10-26
K915667MODEL H170 PEDIATRIC CHEST X-RAY UNITH.L. Lyons Co.1992-01-31
K895034BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15CYamato Medical Corp.1989-11-15
K891395RADKOR BS-10 AND BS-10TRadkor, Inc.1989-04-03
K872132SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMSSopha Medical Systems, Inc.1987-10-26
K862828BSX BUCKY-STANDGarrels X-Ray Products, Inc.1986-08-01
K860454BASICAM S COUNTER BALANCE CAMERASiemens Gammasonics, Inc.1986-02-21

Legacy Summary#

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FDA Review#

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