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Found 3 results
510(k) Data Aggregation
K Number
K981227Device Name
SYMPHONY 360 REMOTE CONTROL TABLE
Manufacturer
ACOMA MEDICAL IMAGING, INC.
Date Cleared
1998-06-30
(88 days)
Product Code
JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ACOMA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Symphony 200 is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology).
Device Description
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K Number
K981131Device Name
PATHFINDER MOBILE C ARM
Manufacturer
ACOMA MEDICAL IMAGING, INC.
Date Cleared
1998-06-26
(88 days)
Product Code
OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ACOMA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pathfinder Mobile C-Arm is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, hip pnnings, and pacemaker implants).
Device Description
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K Number
K963851Device Name
TILTING RADIOGRAPHIC TABLE (REMOTE)
Manufacturer
ACOMA MEDICAL IMAGING, INC.
Date Cleared
1997-01-23
(120 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Applicant Name (Manufacturer) :
ACOMA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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