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510(k) K963936

ACCESSPOINT, MED E-MAIL, DICOM READER by Biosound, Inc. — Product Code LMB

K963936 is an FDA 510(k) premarket notification submitted by Biosound, Inc. for the device "ACCESSPOINT, MED E-MAIL, DICOM READER". The FDA issued a decision of Substantially Equivalent on March 31, 1997. The device falls under product code LMB (Device, Digital Image Storage, Radiological), a Class I device regulated under 21 CFR 892.2010. Biosound, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1997
Date Received
October 1, 1996
Clearance Type
Traditional
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 Biosound, Inc.

  • K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER (July 9, 1997)
  • K963262 — ARTOSCAN M (March 28, 1997)
  • K963662 — GALILEO EVOKED POTENTIALRE (February 26, 1997)
  • K953716 — INTRACAVITY TRANSDUCERS (April 17, 1996)
  • K953530 — DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A (April 8, 1996)
  • K953819 — DIAGNOSTIC ULTRASOUND TRANDUCER (March 1, 1996)
  • K953759 — DIAGNOSTIC ULTRASOUND TRANSDUCER (March 1, 1996)
  • K955458 — ULTRASOUND PROBE BIOPSY ACCESSORIES (February 12, 1996)
  • K953579 — TEE PROBE (February 2, 1996)
  • K953430 — ULTRASOUND PROBE BIOPSY ACCESSORIES (October 24, 1995)

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)
  • K983447 — WISE (II) IMAGE MANAGEMENT SYSTEM (October 29, 1998)
  • 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)
  • K964803 — UNIVISION ECHOCARDIOLOGY SYSTEM (February 11, 1997)

FDA data resources