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510(k) Data Aggregation
K Number
K971848Device Name
TDK MEDICAL GRADE CD-R
Manufacturer
TDK ELECTRONICS CORPORATION OF AMERICA
Date Cleared
1997-08-15
(88 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Applicant Name (Manufacturer) :
TDK ELECTRONICS CORPORATION OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TDK Medical Grade CD-R is a storage medium used for picture archiving and exchange of recordable information. The TDK Medical Grade CD-R is a multisession disc with 650MB capacity, which is used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving.
Device Description
The TDK Medical Grade CD-R is a storage medium used for picture archiving and exchange of recordable information. The TDK Medical Grade CD-R is a multisession disc with 650MB capacity, which is used in conjunction with cardio review stations and mini review stations that accept this type of media. TDK Medical Grade CD-R media provides the following capabilities; acquisition, exchange, display, review and archiving. The TDK Medical Grade CD-R conforms to ISO 9002, Orange Book, Part II.
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