510(k) · Cleared

Cleared

TDK Medical Grade CD-R

K971848510(k) TraditionalCleared Aug 15, 199788-day reviewClass I21 CFR 892.2010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tdk Electronics Corporation of America · LMB Device, Digital Image Storage, Radiological

Cleared on Aug 15, 1997 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Aug 15, 1997
Review: 88 days
Class: Class I
Product code: LMB
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K971848Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LMB devices

LMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMB

FDA has decided no LMB device since 2007.

Median 510(k) review, days · LMB

Too few LMB 510(k)s in any year since 2007 to give a median.

Recalls per year · LMB

1in 2013

2007high 5 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMB

7in 2025

2007high 21 (2016) · low 0 (2015)2025

MAUDE reports naming product code LMB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	1	3
2009	—	5	3
2010	—	0	16
2011	—	2	4
2012	—	0	4
2013	—	1	7
2014	—	0	1
2015	—	0	0
2016	—	0	21
2017	—	0	10
2018	—	0	5
2019	—	0	10
2020	—	0	8
2021	—	0	10
2022	—	0	0
2023	—	0	10
2024	—	0	9
2025	—	0	7
2026	—	0	—

What is it indicated for?

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…

Read the full statement (114 words)

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.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971848 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971848: TDK Medical Grade CD-R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971848

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026