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510(k) K113360

MEDICAL IMAGE PROCESSING UNIT by Humanray Co,Ltd — Product Code EAP

K113360 is an FDA 510(k) premarket notification submitted by Humanray Co,Ltd for the device "MEDICAL IMAGE PROCESSING UNIT". The FDA issued a decision of Substantially Equivalent on February 7, 2012. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Humanray Co,Ltd has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2012
Date Received
November 14, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type

Other clearances by Humanray Co,Ltd

  • K121132 — EZSENSOR P DIGITAL INTRAORAL SENSOR (May 10, 2012)

Other clearances for product code EAP

  • K102573 — PROVU (TM) DENTAL X-RAY SYSTEM (June 30, 2011)
  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K080738 — DENTRON SENSOR (May 13, 2008)
  • K052422 — THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) (September 27, 2005)
  • K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (June 7, 2004)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K960028 — ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM (March 1, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K954565 — EXPLOR-X (AZTEH) HF (October 27, 1995)
  • K951734 — LUMIX 70B (July 20, 1995)

FDA data resources