FDA 510(k) Premarket Notification K950291: DIGITAL 625HF

Submission Details & Decision

Normalized public record details for 510(k) notification K950291.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K950291

Applicant / Sponsor

Fischer Imaging Corp.

Device Name

DIGITAL 625HF

Product Code

IZO

Decision Date

1995-03-23

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

1995-01-25

Related Establishments / Registrations

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DEL MEDICAL, INC. Registration: 1418964 View Registration
SUMMIT INDUSTRIES, LLC Registration: 1450503 View Registration
Varex Imaging Corporation Registration: 1483291 View Registration
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Registration: 2183066 View Registration
SPELLMAN HIGH VOLTAGE ELECTRONICS CORP. Registration: 2429877 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Siemens Healthineers AG Registration: 3002808157 View Registration
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. Registration: 3002975048 View Registration
EMD TECHNOLOGIES INCORPORATED Registration: 3003426669 View Registration
Philips Medical Systems DMC GmbH Registration: 3003768251 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
SHIMANE SHIMADZU CORPORATION Registration: 3003927316 View Registration
Carestream Healthcare International Company, Ltd Registration: 3004105475 View Registration
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. Registration: 3004756607 View Registration
Siemens Healthineers AG Registration: 3004977335 View Registration
MEDICATECH USA Registration: 3004989804 View Registration
DRTECH Corporation Registration: 3005172103 View Registration
CARESTREAM HEALTH, INC., GLOBAL R&D CENTER Registration: 3005778458 View Registration
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Varex Imaging Nederland B.V. Registration: 3006383214 View Registration
DRGEM CORPORATION Registration: 3006551157 View Registration
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SPELLMAN HIGH VOLTAGE ELECTRONICS(SUZHOU INDUSTRIAL PARK)CO.,LTD Registration: 3008152219 View Registration
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SG HEALTHCARE CO LTD Registration: 3009715136 View Registration
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SIEMENS X-RAY VACUUM TECHNOLOGY LTD. Registration: 3011569702 View Registration
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CAN TECHNOMED TRADING LTD. Registration: 3015276088 View Registration
SUZHOU POWERSITE ELECTRIC CO., LTD. Registration: 3018269927 View Registration
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DRGEM Corporation (Gimcheon Factory) Registration: 3029916061 View Registration
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Registration: 8030233 View Registration
GILARDONI S.P.A. Registration: 8043725 View Registration
GE MEDICAL SYSTEMS SCS Registration: 9611343 View Registration
WIPRO GE HEALTHCARE PRIVATE LTD Registration: 9613936 View Registration
GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V. Registration: 9616047 View Registration
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