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510(k) K061302

DIGITAL PRINTER P6000D SERIES, MODEL P6000DU by Mitsubishi Electric Corporation Kyoto Works — Product Code LMC

K061302 is an FDA 510(k) premarket notification submitted by Mitsubishi Electric Corporation Kyoto Works for the device "DIGITAL PRINTER P6000D SERIES, MODEL P6000DU". The FDA issued a decision of Substantially Equivalent on June 23, 2006. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2006
Date Received
May 10, 2006
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

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  • 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)
  • K060440 — CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG (March 16, 2006)

FDA data resources