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510(k) K983447

WISE (II) IMAGE MANAGEMENT SYSTEM by Sectra-Imtec AB — Product Code LMB

K983447 is an FDA 510(k) premarket notification submitted by Sectra-Imtec AB for the device "WISE (II) IMAGE MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 29, 1998. The device falls under product code LMB (Device, Digital Image Storage, Radiological), a Class I device regulated under 21 CFR 892.2010. Sectra-Imtec AB has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1998
Date Received
September 30, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Digital Image Storage, Radiological
Device Class
Class I
Regulation Number
892.2010
Review Panel
RA
Submission Type

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

Other clearances by Sectra-Imtec AB

  • K040376 — SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE (May 4, 2004)
  • K033712 — MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 (December 23, 2003)
  • K031590 — SECTRA ORTHOPEDIC PACKAGE (October 2, 2003)
  • K021527 — SECTRA OSTEOPOROSIS PACKAGE (June 7, 2002)
  • K002936 — MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM (October 17, 2000)
  • K965161 — SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) (March 12, 1997)
  • K963395 — IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM (October 25, 1996)
  • K961983 — TRS 2000 TELERADIOLOGY SYSTEM (August 13, 1996)

Other clearances for product code LMB

  • K992131 — SAMSUNG RAYPAX LONG TERM ARCHIVE (September 13, 1999)
  • K984405 — ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 (February 8, 1999)
  • K980243 — PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) (April 3, 1998)
  • K973463 — OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE (December 2, 1997)
  • K973413 — ID. STORE (RELEASE 2.0) (November 25, 1997)
  • K972380 — KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) (September 11, 1997)
  • K971848 — TDK MEDICAL GRADE CD-R (August 15, 1997)
  • K971451 — WISE IMAGE MANAGEMENT SYSTEM (June 26, 1997)
  • K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER (March 31, 1997)
  • K964803 — UNIVISION ECHOCARDIOLOGY SYSTEM (February 11, 1997)

FDA data resources