THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)— 510(k) K052422

Name: FDA 510(k) clearance K052422
Creator: U.S. Food and Drug Administration
Published: 2005-09-27

Substantially Equivalent

Flow X-Ray Corp.

FDA 510(k) clearance K052422 for THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE), Substantially Equivalent on 2005-09-27. Applicant: Flow X-Ray Corp.. Device class: 2.

Clearance details

Applicant: Flow X-Ray Corp.
Product code: Code EAP
Device class: Class 2
Regulation: 21 CFR 872.1810
Advisory panel: Dental
Date received: 2005-09-02
Decision date: 2005-09-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EAP

view all

K113360 — MEDICAL IMAGE PROCESSING UNIT2012-02-07
K102573 — PROVU (TM) DENTAL X-RAY SYSTEM2011-06-30
K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM2009-11-30
K080738 — DENTRON SENSOR2008-05-13
K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM2004-06-07

More clearances from Flow X-Ray Corp.

view all

K791522 — FLOW MEDICAL X-RAY PROTECTIVE GLOVES1979-10-26

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