Free 2785 - Federal

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION

FIELD TEST SERIAL NO. (1-8)

DENTAL RADIOGRAPHIC SYSTEMS FIELD TEST RECORD

(Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)

Print Legibly. Use Black Ball Point Pen. Enter One Character Per Box. Do Not Write in Shaded Area.

DR
REGIONAL REVIEW (NAME)

Card No.
(9-10)

Test Procedure 1.

Component Certification Information 2. Indicate the Status of Each as Follows: C - Certified N - Not Certified V - Certified with a Variance X - Not Present

DR
11 13

14 16

Beam Limiting Device

15 17

X-Ray Controls Tube Housing Assembly With High Voltage Generator Tube Housing Assembly With Beam Limiting Device And High Voltage Generator

Tube Housing Assembly

18

Tube Housing Assembly With Beam Limiting Device Other (Specify in Remarks)

19

20

10
Tube Housing Assembly Information 3(a). Manufacturer Mfr. Code

21
3(b). Model No. Serial No. Date of Mfr Unique ID

24

25
Mo/Yr

30 47

31

43

44

Beam Quality/Reproducibility MDH (Pulse Exposure) Over 70 kV - 4.5 mm Al 50-70 kV - 3.0 mm Al

Technique Factors 4.
kVP

5.

48
6.
q

50

Over 70, if possible, if not, max value
sec. OR

mA

51
pulses

53

58

60

54
7.
q

57
mAs

61
Beam Quality: 8.

64

q

mR

@
16

q

mm Al

Over 70 kV 4.5mm

50-70 kV 3.0mm

11
9.
q

15
mR

17
q

@
23

mm Al

3.5mm

2.0mm

18
10.
q

22
mR

24
q

@
30

mm Al

2.5mm

1.5mm

25
Minimum SSO 11.
q

29
mR

31
q

11

MDH (Pulse Exposure) No Al in Beam

@
37

mm Al

1.5mm

1.0mm

32
Reproducibility 12.
q

36

38

13.
mR msec

39
14. S5

43
q

43
mR

44 15. 53 17.
mR

47
msec

48
16.
q

52

56
msec

57
18.
q

61
mR

62 19. 71

65
msec

66

70
Page 1 of 2 Pages

74
Created by: PSC Media Arts Branch (301) 443-2454

FORM FDA 2785 (5/82)

EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION

FIELD TEST SERIAL NO. (1-8)

DENTAL RADIOGRAPHIC SYSTEMS FIELD TEST RECORD

(Use Form FDA 2782, Field Test Record Continuation, if more space is needed.)
Reproducibility (Continued) 20.
q

Print Legibly. Use Black Ball Point Pen. Enter One Character Per Box. Do Not Write in Shaded Area.

DR
REGIONAL REVIEW (NAME)

21.
mR

11
22.
q

15
mR

20
24.

24
q

Data Here If Any Of Items 12, 14, 16 And 18 Differ By More Than 10 Percent Of Largest Value

msec

16
23.

19
msec

25
25.

28
msec

12
26.

mR

29
q

33
27.
mR

34

37
msec

38
28.
q

42
29.
mR

43

46
mRm

47
30.
q

51
31.
mR

52

55
msec

56

60

61

64

Linearity 32.
mA

Field Size And Shape At Min SSD 37. 38. Field Shape R - Rectangular
cm

11 13 If Change in mA Causes a kVp Shift, Readjust kVp Setting to Value Selected at Item 4 Above.
33.
q

14 C - Circular

Field Size

q

15

17

Minimum Source To Skin Distance:
mR

18
34.
q

22
mR

39. Outside Separation of Image of Focal Spot Strips
q

cm

28

30

23
35.
q

27
mR

31
36.
q

35
mR

13

36

40

41. Warning Label Present

Y - YES N - NO

Functional Requirements: 40. If Multiple Tubes Controlled By Single Exposure Switch, Then Indication Of Tube Selection Both At Control Panel And At Selected Tube Y - YES N - NO 41 X - N/A Y - YES 42. N - NO Technique Factors Visible At Operator's Position 43 Y - YES N - NO

42
43. Exposure Terminated After Present Time Interval, Preset mAs, Or Preset Number of Pulses 44. Timer Resets To Zero Or Initial Setting When Exposure Switch Disengages Remarks

44

45

Y - YES N - NO X - N/A

45. An Exposure Can Be Made With Timer In Zero Or Off Position

46

Y - YES N - NO X - N/A

CHECK IF CONTINUATION SHEET USED

FORM FDA 2785 (5/82)

Page 2 of 2 Pages