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510(k) K984252

IMATION TRIMATIC DIGITAL SYSTEM by Imation Corp. — Product Code LMA

K984252 is an FDA 510(k) premarket notification submitted by Imation Corp. for the device "IMATION TRIMATIC DIGITAL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 25, 1999. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Imation Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1999
Date Received
November 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digitizer, Image, Radiological
Device Class
Class II
Regulation Number
892.2030
Review Panel
RA
Submission Type

Other clearances by Imation Corp.

  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)
  • K973303 — IMATION MODEL 9410 NETWORK INTERFACE (November 25, 1997)
  • K972163 — IMATION SE-196 LASER IMAGER (September 5, 1997)
  • K962750 — 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESS (August 21, 1996)

Other clearances for product code LMA

  • K132183 — DICOM VIDEO (October 3, 2013)
  • K130636 — TELERADPRO EDGE; TELERADPRO EDGE HD-CCD (June 7, 2013)
  • K130406 — DIAGNOSTICPRO EDGE (April 29, 2013)
  • K102476 — TELERADPRO (October 7, 2010)
  • K093809 — VIDAR DENTAL FILM DIGITIZER (January 7, 2010)
  • K091288 — MEDI-6000 MEDICAL IMAGE DIGITIZER (August 14, 2009)
  • K063424 — FILM DIGITZER, MODEL 2908 MAMMO PRO (December 21, 2006)
  • K042484 — NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER (October 20, 2004)
  • K033637 — MEDICAL IMAGE DIGITIZER, MODEL 2908 (December 17, 2003)
  • K032022 — DIGITAL IMAGER (September 2, 2003)

FDA data resources