MEDICAL IMAGE PROCESSING UNIT— 510(k) K113360

Substantially Equivalent

Humanray Co,Ltd

FDA 510(k) clearance K113360 for MEDICAL IMAGE PROCESSING UNIT, Substantially Equivalent on 2012-02-07. Applicant: Humanray Co,Ltd. Device class: 2.

Clearance details

Applicant: Humanray Co,Ltd
Product code: Code EAP
Device class: Class 2
Regulation: 21 CFR 872.1810
Advisory panel: Dental
Date received: 2011-11-14
Decision date: 2012-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EAP

K102573 — PROVU (TM) DENTAL X-RAY SYSTEM2011-06-30
K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM2009-11-30
K080738 — DENTRON SENSOR2008-05-13
K052422 — THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)2005-09-27
K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM2004-06-07

More clearances from Humanray Co,Ltd

K121132 — EZSENSOR P DIGITAL INTRAORAL SENSOR2012-05-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.