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510(k) K945580

Device
DSP OPTION
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
510(k) number
K945580
Product code
IZJ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-30
Date received
1994-11-14
Regulation
892.1620
Classification name
Camera, X-ray, Fluorographic, Cine Or Spot
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT L TUROCY
Address
595 Miner Rd. Cleveland OH US 44143 44143

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IZJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K024085CCD CAMERA, MODEL PKP-06000-000Perkins Electronics Co.2003-03-11
K972130DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVRFairmontmedical1997-10-09
K920793PHILIPS DSI SYSTEM RELEASE 3.2Philips Medical Systems, Inc.1992-07-17
K896615CINE CAMERA CONTROL MODEL PK2037Perkins Mfg. Co.1990-01-04
K881688DTV-4114 FLUOROSCOPIC TELEVISION CAMERAAdac Laboratories1988-05-18
K853983CANON X-RAY 35MM CINE CAMERA CSI-35Canon USA, Inc.1985-10-16
K812613VIDICAM 200Diversified P.A.1981-12-08
K810191SIRCAM 103Siemens Corp.1981-02-26
K810072105MM ROLL FILM FLUOROGR. CAMERA, #105Scientex Corp.1981-02-12
K802132105MM SPOT FILM CAMERAInstrumentation Camera, Inc.1980-10-23
K792394SIRCAM 106Siemens Corp.1979-12-20

Legacy Summary#

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FDA Review#

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