# K971848: TDK Medical Grade CD-R

- Pathway: 510(k) (Traditional)
- Applicant: Tdk Electronics Corporation of America
- Decided: Aug 15, 1997 after 88 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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. The TDK Medical Grade CD-R conforms to 1SO 9002, Orange Book, Part I1. TDK Medical Grade CD-R should be used only by persons thoroughly trained in the use of the specific picture archiving and communication system being used, with special attention to training in the use of the write/read hardware.

Source page: https://510kreport.com/device/K971848
Methodology: https://510kreport.com/methodology