REPORT OF ASSEMBLY OF X-RAY SYSTEMS
Report of assembly of X-ray systems (i.e., not reported on FEDERAL FORM FDA 2579) is applicable to installations or
acquisitions from sale, lease, transfer, or relocation of radiation machines and/or major components. Completing and filing this
form to report the assembly or installation of an X-ray system or sub-system are required by State of North Carolina regulations.
Anyone engaged in the business of assembling, replacing, or installing one or more components into an X-ray system is considered
an assembler and is subject to this requirement. This report should be filed within 15 days following the assembly/installation.
N.C. Radiation Protection Section
1645 Mail Service Center, Raleigh, North Carolina 27699 – 1645 Phone: (919) 571-4141
Equipment Location
Assembler Information
Reg #
a. NAME OF HOSPITAL, DOCTOR OR OFFICE WHERE INSTALLED
a. COMPANY NAME
b. STREET ADDRESS
b. STREET ADDRESS
c. CITY
d. STATE
e. ZIP CODE
FAX: (919) 571-4148
c. CITY
f. TELEPHONE NUMBER
Reg #
d. STATE
e. ZIP CODE
f. TELEPHONE NUMBER
General information
a. THIS REPORT IS FOR ASSEMBLY OF CERTIFIED COMPONETS WHICH ARE (Check appropriate box(es))
REASSEMBLY – MIXED SYSTEM (Both certified and non-certified component)
REPLACEMENT COMPONENTS IN AN EXISTING SYSTEM
AN ADDITION TO AN EXISTING SYSTEM
NEW ASSEMBLY – FULLY CERTIFIED SYSTEM
REASSEMBLY – FULLY CERTIFIED SYSTEM
b. INTENDED USE(S) (Check Appropriate box(es))
GENERAL PURPOSE RADIOGRAPHY
GENERAL PURPOSE FLUOROSCOPY
TOMOGRAPHY (Other than CT)
ANGIOGRAPHY
PODIATRY
UROLOGY
MAMMOGRAPHY
CHEST
CHIROPRACTIC
CT HEADSCANNER
c. THE X-RAY SYSTEM IS (Check one)
STATIONARY
CT WHOLE BODY SCANNER
HEAD-NECK (Medical)
DENTAL-INTRAORAL
DENTAL-CEPHALOMETRIC
DENTAL PANORAMIC
d. THE MASTER CONTROL IS IN ROOM
RADIATION THERAPHY SIMULATOR
C-ARM FLUOROSCOPIC
DIGITAL
BONE MINERAL ANALYSIS
DENTAL-CT
OTHER (Specify in comments)
e. DATE OF ASSEMBLY
MOBILE
Component information
a. THE MASTER CONTROL IS
A NEW INSTALLATION
EXISTING (Certified)
EXISTING (Non-certified)
b. CONTROL MANUFACTURER
c. CONTROL SERIAL NUMBER
e. CONTROL MODEL NUMBER
d. DATE MANUFACTURED
f. SYSTEM MODEL NAME (CT Systems Only)
g. COMPLETE THE FOLLOWING TO LIST HOW MANY OF EACH COMPONENT ARE INSTALLED IN THIS SYSTEM USING THE APPROPRIATE BOX.
X-RAY CONTROL
HIGH VOLTAGE GENERATOR
VERTICAL CASSETTE HOLDER
TUBE HOUSE ASSEMBLY (medical)
DENTAL TUBE HEAD
BEAM LIMITING DEVICE
FILM CHANGER
IMAGE INTENSIFIER
SPOT FILM DEVICE
TABLE
CRADLE
OTHER ______________
Assembler Signature
I affirm that all certified components assembled or installed by me for which this report is being made, were adjusted and tested by me according to the
instructions provided by the manufacturer(s) and were installed in accordance with of 15A NCAC 11 .0210.
a. PRINTED NAME
b. SIGNATURE
c. DATE
Comments
Report of Assembly of X-ray Systems
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State of North Carolina | Division of Health Service Regulation | Radiation Protection Section | Registration Branch
N.C. DHHS is an equal opportunity employer and provider.
Rev. 08/14/12