United States Securities And Exchange Commission
Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported):  January 7, 2014

ISORAY, INC.

(Exact name of registrant as specified in its charter)

Minnesota
(State or other jurisdiction
of incorporation)
001-33407
(Commission
File Number)
41-1458152
(IRS Employer
Identification No.)

 

350 Hills Street, Suite 106, Richland, Washington 99354

(Address of principal executive offices) (Zip Code)

 

(509) 375-1202

(Registrant's telephone number)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
     
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
     
o     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
     
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 
 

 

ITEM 8.01 Other Events

 

On January 7, 2014, IsoRay, Inc. (the "Company"), issued a press release announcing the Company’s receipt of 510(k) approval from the FDA to market Cesitrex™ (liquid Cs-131) with the GliaSite® radiation therapy system.

 

ITEM 9.01 Exhibits

 

(c) Exhibits
   
99.1 Press Release issued by IsoRay, Inc., dated January 7, 2014
   
99.2 Section 510(k) Clearance from the Food and Drug Administration to market Cesitrex with the GliaSite Radiation Therapy System, dated December 17, 2013

 

 

SIGNATURES

 

In accordance with the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

Dated: January 7, 2014

 

  IsoRay, Inc., a Minnesota corporation
   
  By:  /s/ Dwight Babcock
    Dwight Babcock, CEO