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510(k) K972163

IMATION SE-196 LASER IMAGER by Imation Corp. — Product Code LMC

K972163 is an FDA 510(k) premarket notification submitted by Imation Corp. for the device "IMATION SE-196 LASER IMAGER". The FDA issued a decision of Substantially Equivalent on September 5, 1997. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Imation Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1997
Date Received
June 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type

Other clearances by Imation Corp.

  • K984252 — IMATION TRIMATIC DIGITAL SYSTEM (January 25, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)
  • K973303 — IMATION MODEL 9410 NETWORK INTERFACE (November 25, 1997)
  • K962750 — 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESS (August 21, 1996)

Other clearances for product code LMC

  • K141454 — SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD (June 26, 2014)
  • K141346 — SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD (June 26, 2014)
  • K111566 — DRYVIEW CHROMA IMAGING SYSTEM (October 6, 2011)
  • K092280 — CYPHER DICOM PRINT SOLUTION (October 16, 2009)
  • K090469 — CARESTREAM DRYVIEW 5850 LASER IMAGER (May 22, 2009)
  • K083522 — SONY UP-DF750 DIGITAL FILM IMAGER (January 9, 2009)
  • K081637 — LASER IMAGER DRYPRO MODEL 873 (July 1, 2008)
  • K072680 — DRYSTAR AXYS, MODEL EYZ4E (October 25, 2007)
  • K061999 — DRY LASER IMAGER, DRYPRO MODEL 832 (August 15, 2006)
  • K061302 — DIGITAL PRINTER P6000D SERIES, MODEL P6000DU (June 23, 2006)

FDA data resources