TDK Medical Grade Cd-R

Q: What is the product code of K971848?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.

FDA 510(k) K971848 · Tdk Electronics Corporation of America

Substantially Equivalent

510(k) numberK971848

Submission

Device name: TDK Medical Grade Cd-R
Applicant: Tdk Electronics Corporation of America
Port Washington, NY, US
Received: May 19, 1997
Decision date: August 15, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: LMB – Device, Digital Image Storage, Radiological
Device class: Class I (low risk)
Regulation: 21 CFR 892.2010
Specialty: Radiology

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

Other 510(k)s with product code LMB

510(k)	Device	Applicant	Decision
K992131	Samsung Raypax Long Term ArchiveLMB · Traditional	Samsung Sds Co., Ltd.	09/13/1999SE
K984405	Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000LMB · Traditional	Intracom Corp.	02/08/1999SE
K983447	Wise (II) Image Management SystemLMB · Special	Sectra-Imtec AB	10/29/1998SE
K980243	Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)LMB · Traditional	Parameter Developments, Inc.	04/03/1998SE
K973463	Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, ArchiveLMB · Traditional	O Tech, Inc.	12/02/1997SE
K973413	Id. Store (Release 2.0)LMB · Traditional	I.S.G. Technologies, Inc.	11/25/1997SE
K972380	Kodak Digital Science (KDS) Medical Image and Information Library (Miil)LMB · Traditional	Eastman Kodak Company	09/11/1997SE
K971451	Wise Image Management SystemLMB · Traditional	O Tech, Inc.	06/26/1997SE
K963936	Accesspoint, Med E-Mail, Dicom ReaderLMB · Traditional	Biosound, Inc.	03/31/1997SE
K964803	Univision Echocardiology SystemLMB · Traditional	Network Concepts, Inc.	02/11/1997SE

Questions and answers

When was TDK Medical Grade Cd-R cleared by the FDA?

TDK Medical Grade Cd-R (K971848) received a 510(k) decision of Substantially Equivalent on August 15, 1997, 88 days after the submission was received.

What is the product code of K971848?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.