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510(k) K926348

SC1000 SCAN CONVERTER by Perkins Mfg. Co. — Product Code LMB

K926348 is an FDA 510(k) premarket notification submitted by Perkins Mfg. Co. for the device "SC1000 SCAN CONVERTER". The FDA issued a decision of Substantially Equivalent on November 19, 1993. The device falls under product code LMB (Device, Digital Image Storage, Radiological), a Class I device regulated under 21 CFR 892.2010. Perkins Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1993
Date Received
December 17, 1992
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 Perkins Mfg. Co.

  • K972136 — TV MONITOR (P12/17) (June 26, 1997)
  • K954222 — VIDEO ENHANCEMENT UNIT (December 8, 1995)
  • K920550 — DISPLAY PROCESSOR - MODEL IDP5100 (April 13, 1992)
  • K915232 — GRUNDIG ELECTRONICS VARIOUS MODELS (January 9, 1992)
  • K910384 — VIDEO ANNOTATOR MODEL PK2310 (April 16, 1991)
  • K904986 — PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 (December 4, 1990)
  • K904540 — VIDEO SYSTEM INTERFACE MODELS (October 26, 1990)
  • K896615 — CINE CAMERA CONTROL MODEL PK2037 (January 4, 1990)
  • K895500 — PATIENT POSITIONING ACCESSORIES (November 6, 1989)
  • K893644 — PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER (August 9, 1989)

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)
  • K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER (March 31, 1997)

FDA data resources