Medivision Series 5000 Fluoroscopic Digital Imager

Q: What is the product code of K844132?

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) K844132 · Sigma Teleproducts, Inc.

Substantially Equivalent

510(k) numberK844132

Submission

Device name: Medivision Series 5000 Fluoroscopic Digital Imager
Applicant: Sigma Teleproducts, Inc.
Hauppauge, NY, US
Received: October 23, 1984
Decision date: January 22, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K971848	TDK Medical Grade Cd-RLMB · Traditional	Tdk Electronics Corporation of America	08/15/1997SE
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

Questions and answers

When was Medivision Series 5000 Fluoroscopic Digital Imager cleared by the FDA?

Medivision Series 5000 Fluoroscopic Digital Imager (K844132) received a 510(k) decision of Substantially Equivalent on January 22, 1985, 91 days after the submission was received.

What is the product code of K844132?

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