Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mathematical modeling and calculations based on pre-defined anatomical models, with no mention of AI or ML terms or concepts.

Therapeutic

No
This device calculates radiation doses received by internal organs; it does not directly treat or diagnose a disease or condition. While it aids in assessing exposure from radiopharmaceuticals, this is a measurement and not a therapeutic action itself.

Diagnostic

Yes

Explanation: The device estimates radiation doses to internal organs caused by radiopharmaceuticals, which is information used for diagnostic purposes (e.g., assessing the impact of a diagnostic procedure or guiding future interventions). Its intended use aligns with providing data for medical evaluation.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is "personal computer code" and calculates radiation doses based on administered radiopharmaceuticals, indicating it is a software program performing calculations. There is no mention of accompanying hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, Olinda EXM is NOT an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes.
Olinda EXM's Function: Olinda EXM is a software program that estimates radiation doses to internal organs after a radiopharmaceutical has been administered to a patient. It uses mathematical models and information about the radiopharmaceutical and the patient's characteristics to perform these calculations.
No Specimen Examination: The description does not mention Olinda EXM analyzing any biological specimens from the patient. Its input is information about the radiopharmaceutical and the patient model, not laboratory test results from a specimen.
Purpose: Its purpose is to estimate radiation dose, which is a calculation related to the in vivo (within the body) behavior of the radiopharmaceutical, not a diagnostic test performed on a specimen.

Therefore, Olinda EXM falls outside the scope of an In Vitro Diagnostic device. It is a software tool used for internal dosimetry calculations.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The purpose of Olinda EXM is to estimate the radiation dose received by internal organs as a result of administering a radiopharmaceutical.

Product codes (comma separated list FDA assigned to the subject device)

90 IYX

Device Description

The personal computer code OLINDA, which is an acronym standing for Organ Level INternal Dose Assessment/EXponential Modeling, calculates radiation doses to different organs of the body from radiopharmaceuticals which are administered systemically (mostly intravenously, but sometimes by oral or inhalation intake routes).

The code requires input from the user on:

Which radionuclide is to be used.
A choice of body model(s) to represent the subject(s) of interest models exist for adult males, adult females, children, and women at different stages of pregnancy, and a number of individual organ systems (not included in the body phantoms).
Parameters which describe the biokinetics of the radiopharmaceutical within different organs of the body with time. Specifically, a potential user needs to provide the time integral of activity in all important source organs of the body. Alternatively, the user may provide biokinetic data and the EXM portion of the code will fit these data to a model, calculate the necessary integrals, and pass them to the OLINDA portion.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Adrenals, Brain, Gall Bladder Wall, Gall Bladder Cont, Lower Large Intestine Wall, Lower Large Intestine Cont, Small Intestine, Stomach Wall, Stomach Cont, Upper Large Intestine Wall, Upper Large Intestine Cont, Heart Wall, Heart Cont, Kidneys, Liver, Lungs, Spleen, Pancreas, Prostate, Skeleton, Active Marrow, Skin, Thyroid, Thymus, Testes, Urin.Bl. Wall, Urin.Bl. Cont, Whole Body

Indicated Patient Age Range

Adult males, adult females, children, and women at different stages of pregnancy (models available for 5 year-old, 6-month pregnant woman).

Intended User / Care Setting

Used by physicists to investigate new radiopharmaceuticals, and estimate patient doses. Used in universities, pharmaceutical manufacturing firms, government agencies, hospitals and research facilities. Both programs need trained professional personnel to operate the program, provide the appropriate input and interpret the results.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2004

Mr. Michael G. Stabin, Ph.D., CHP Assistant Professor of Radiology and Radiological Sciences Vanderbilt University 1161 21st Avenue South NASHVILLE TN 37232-2675

Re: K033960

Trade/Device Name: OLINDA EXM Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: 90 IYX Dated: May 19, 2004 . Received: May 20, 2004

Dear Dr. Stabin:

This letter corrects our substantially equivalent letter of June 15, 2004 regarding the typo for the incorrect regulatory class. The June 15th letter stated this device as class II instead of class I.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications ) for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

1

Page 2 - Dr. Stabin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Vividh. Lyam

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known):	K033960
Device Name:	Olinda EXM
Indications For Use:	The purpose of Olinda EXM is to estimate the radiation dose received by internal organs as a result of administering a radiopharmaceutical.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use

(Per 21 CFR 801.109)	✓
------------------------------------------	--------------------------------------

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Signature

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	K033960
---------------	---------

۽

:

公司

:

3

K033960

JUN 1 5 2004

510(k) Summary

Applicants name address, phone and fax: Vanderbilt University

Contact persons name and address: Michael Stabin Vanderbilt Universitv 1161 21st Avenue South Nashville, TN 37232-2675

Telephone / Fax number of contact: (615) 343-0068 / (615) 322-3764

Date Summary prepared:

Trade Name: OLINDA/EXM

Common Name: Organ Level !Nternal Dose Assessment/EXponential Modeling Classification: Not yet classified

Devices OLINDA/EXM is substantially equivalent to: CDI3, Computer Program for Tissue Doses in Diagnostic Radiology, distributed by the Food and Drug Administration. CAMIRD, distributed by the Biomedical Computing Technology Information Center, Oak Ridge National Laboratory, PO Box X, Oak Ridge TN 37830.

Description of OLINDA/EXM:

The personal computer code OLINDA, which is an acronym standing for Organ Level INternal Dose Assessment/EXponential Modeling, calculates radiation doses to different organs of the body from radiopharmaceuticals which are administered systemically (mostly intravenously, but sometimes by oral or inhalation intake routes).

The code requires input from the user on:

1. Which radionuclide is to be used.
1. A choice of body model(s) to represent the subject(s) of interest models exist for adult males, adult females, children, and women at different stages of pregnancy, and a number of individual organ systems (not included in the body phantoms).
1. Parameters which describe the biokinetics of the radiopharmaceutical within different organs of the body with time. Specifically, a potential user needs to provide the time integral of activity in all important source organs of the body. Alternatively, the user may provide biokinetic data and the EXM portion of the code will fit these data to a model, calculate the necessary integrals, and pass them to the OLINDA portion.

4

The code works in the Windows 2000 or Windows XP Professional operating environments.

Intended Use of Olinda EXM: The purpose of OLINDA/EXM is to estimate radiation doses received by internal organs as a result of administering a radiopharmaceutical.

Comparison to CAMIRD

This program was legally distributed by the Biomedical Computing Technology Information Center, Oak Ridge National Laboratory, PO Box X, Oak Ridge TN 37830 in April 1976. It was described in a paper by Feller (1976), a copy of which is attached. It has been used by others and is referred to in a paper by Bellina and Guzzardi (1980). It is a pre-amendment device. It has not been through a 510(k) process and does not have a document control number. It has not been classified. Three versions of CAMIRD were written. The comparison here is to version II.

Comparison	CAMIRD	OLINDA/EXM
Indications for
use	Estimates the
absorbed doses to
several tissues of a
reference patient for a
specified
radiopharmaceutical
dosage	Estimates the absorbed
doses to several tissues
of a reference patient
for a specified
radiopharmaceutical
dosage.	Equivalent.
Both calculate
dose per unit
input.
Target
population	Specific patients and
patient groups not
targeted. Calculations
are based on models of
an average individual
(reference adult
male).	Specific patients and
patient groups not
targeted. Calculations
are based on models of
average individuals. 10
models are available
e.g. adult male, female,
5 year-old, 6-month
pregnant woman.	Target
population
equivalent.
OLINDA/EXM
has a larger
number of
phantoms.
Design	User specified
radiopharmaceutical
kinetic parameters and
previous Monte Carlo
calculated organ
contributions.
Algorithm: MIRD method
(Loevinger et al. 1988)	User specified
radiopharmaceutical
kinetic parameters and
previous Monte Carlo
calculated organ
contributions.
Algorithm: MIRD method
(Loevinger et al. 1988)	The programs
are essentially
equivalent in
input and
output. The
main difference
is in the number
of body models
available.
	Input:	Input:
	1. Radionuclide

Body model
Radiopharmace
utical
biokinetics | 1. Radionuclide
Body model
Radiopharmaceutical
biokinetics | |
| Energy used
and/or delivered | The program estimates
doses from user-
entered criteria and
precalculated data; it
is not connected to an
energy-emitting
device. | The program estimates
doses from user-entered
criteria and
precalculated data; it is
not connected to an
energy-emitting device. | Equivalent |
| Performance | Output of dose per
unit input.
Simpler system than
OLINDA/EXM. Fortran
IV, input driven
program. Only 1 body
phantom, fewer organs
in output. | Output of dose per unit
input.
User friendly, event
driven, more body
phantoms, more organs
in output. | OLINDA/EXM is
equivalent in
performance to
CAMIRD. |
| Human Factors | A descriptive paper is
available in the open
literature. | Communication tools for
error prevention have
been systematically
implemented. Error
messages, help files.
user manual and
installation tests have
all been developed so as
to educate the user and
prevent mistakes. An
open literature
publication is in
preparation describing
the OLINDA/EXM code.
An open literature
publication is available
describing the MIRDOSE
code (Stabin 1996), on
which the OLINDA/EXM
code was based. | OLINDA/EXM is
more user-
friendly. |
| Anatomical sites | Program Tissue doses
calculated: Adrenals,
Fat, Blood, ovaries,
Skin, Uterus, Lower
| Tissue doses calculated:
Adrenals, Brain, Gall
Bladder Wall, Gall
Bladder Cont, Lower
Large Intestine Wall,
Lower Large Intestine | More tissues
included in
OLINDA/EXM. |

5

:

6

dose factors are based have been established previously in the literature (Cristy and Eckerman 1987, Stabin et al. 1995) and have been widely accepted and and Eckennan 1707, on one one one one only . Both programs are limited in that they use average body models and thus are not representative of any chat they use areful gu new has more body models to choose from and also particular pations. Sales the mass of individual organs to provide a limited measure of patient-specificity. Both programs are intended to be used by mcasure oversicists or appropriately trained physicians or equivalent in research er hospital facilities. Both programs need trained professional personnel to operate the program, provide the appropriate input and interpret the results.

References

Bellina CR and Guzzardi R. CAMIRD/III: a revised version of the CAMIRD/II and MIRD-S packages for internal dose calculation: concise communication. Journal of Nuclear Medicine, Vol 21, Issue 4 379-383 1980.

Cristy M. and Eckerman K. Specific absorbed fractions of energy at various ages from internal photons sources. ORNL/TM-8381 V1-V7. Oak Ridge National Laboratory, Oak Ridge, TN; 1987.

Feller PA. Computer Software to Facilitate Absorbed Dose Calculations, , in Radiopharmaceutical Dosimetry Symposium -- Proceedings of a Conference Held at Oak Ridge, Tenn., April 26-29, 1976, ed. by R.J. Cloutier, J.L. Coffey, W.S. Snyder and E.E. Watson, pp.119-126, HEW Publication (FDA) 76-8044, June 1976.

International Commission on Radiological Protection. 1990 Recommendations of the International Commission on Radiological Protection. ICRP Publication 60, Pergamon Press, New York, 1991.

Loevinger R, Budinger T, Watson E: MIRD primer for absorbed dose calculations. Society of Nuclear Medicine; 1988.

Peterson LE and Rosenstein M. Computer program for tissue doses in diagnostic radiology. Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 1989.

Rosenstein, M. HEW Publication FDA 76-8030, Food and Drug Administration, Rockville. Marvland. 1976.

Stabin M. MIRDOSE - the personal computer software for use in internal dose assessment in nuclear medicine. J Nucl Med, 37:538-546; 1996.

7

Stabin MG, da Luz CQPL. New decay data For internal and external dose assessment, Health Phys. 83(4):471-475, 2002.

Stabin MG and Siegel JA. Physical Models and Dose Factors for Use in Internal Dose Assessment. Health Physics, 85(3):294-310, 2003.

Comparison to CDI3

This program is distributed by the Food and Drug Administration through their web site www.fda.gov. It has been available since 1989 and is widely available in the radiation protection community. It has not been through a 510(k) process and does not have a document control number. It has not been classified.

Comparison	CDI3	OLINDA/EXM	Discussion
Indications for
use	Estimates the absorbed
doses to various tissues
of a reference patient
for a number of
specified X-ray
procedures. The
program also calculates
a "cancer detriment
index" for the aggregate
of the tissue doses.	Estimates the absorbed
doses to several tissues of
a reference patient for a
specified
radiopharmaceutical
dosage.	First indication
essentially
equivalent.
OLINDA/EXM
does not
calculate
"cancer
detriment
index"
Target
population	Specific patients and
patient groups not
targeted. Calculations
are based on model of
average human body
"phantom".	Specific patients and
patient groups not
targeted. Calculations are
based on models of
average individuals. 10
models are available e.g.
adult male, female, 5
year-old, 6-month
pregnant woman.	Target
population
equivalent.
OLINDA/EXM
has a larger
number of
phantoms.
Design	X-ray examination input
parameters are
combined with
previously established
Monte Carlo calculations
of dose per unit input to
give dose estimates.
Algorithm given in
section 4 of "Organ
doses in diagnostic
radiology" (Rosenstein
1976).	User specified
radiopharmaceutical
kinetic parameters and
previous Monte Carlo
calculated organ
contributions. Algorithm:
MIRD system (Loevinger et
al. 1988)
Input:
Radionuclide

                                                                                                    | Different

algorithms,
similar inputs,
same output. |
| | Input: | | |
| | 1. X-ray Spectra data | 8. Body model | |
| | 2. Exposure parameters
(entrance exposure, R,
source/image distance,
receptor size) | 9. Radiopharmaceutic
al biokinetics | |
| | 3. Projection
parameters | Output: Dose to organs in
mSv/MBq and rem/mCi. | |
| | Out put: Dose to organs
in mrad | | |
| Energy used
and/or
delivered | The program estimates
doses from user-entered
criteria and
precalculated data; it is
not connected to an
energy-emitting device. | The program estimates
doses from user-entered
criteria and precalculated
data; it is not connected
to an energy-emitting
device. | Equivalent |
| | | | |
| Performance | Output of dose per unit
input.
DOS-based, input driven
program. Fewer body
phantoms.
Fewer organs in output. | Output of dose per unit
input.
User friendly,
Event driven
More body phantoms
More organs in output.
Communication tools for
error prevention have
been systematically
implemented. Error
messages, help files, user
manual and installation
tests have all been
developed so as to | OLINDA/EXM is
equivalent in
performance to
CDI3. |
| | | | educate the user and
prevent mistakes. |
| Human Factors | A user's manual was
published by the FDA
(Peterson and
Rosenstein 1989).
Current availability is
uncertain. | An open
literature publication is in
preparation describing the
OLINDA/EXM code. An
open literature
publication is available
describing the MIRDOSE
code (Stabin 1996), on
which the OLINDA/EXM
code was based. | OLINDA/EXM is
equivalent to
CDI3 given the
current state of
computer
technology. |
| | | | |
| Anatomical
sites | Program Tissue doses
calculated: lungs,
active bone marrow,
ovaries, testes, thyroid,
uterus, total trunk
(excluding skeletal and
lung tissues), and female | Tissue doses calculated:
Adrenals, Brain, Gall
Bladder Wall, Gall Bladder
Cont, Lower Large
Intestine Wall, Lower
Large Intestine Cont,
Small Intestine, Stomach | More tissues
are included in
OLINDA/EXM. |
| | | | |
| | breasts. | Wall, Stomach Cont, | |
| | | Upper Large Intestine | |
| | | Wall, Upper Large | |
| | | Intestine Cont, Heart | |
| | | Wall, Heart Cont, Kidneys, | |
| | | Liver, Lungs, Spleen, | |
| | | Pancreas, Prostate, | |
| | | Skeleton, Active Marrow, | |
| | | Skin, Thyroid, Thymus, | |
| | | Testes, Urin.Bl. Wall, | |
| | | Urin.Bl. Cont, Whole Body | |
| Compatibility
with other
devices | The only device that the
program interacts with is
the PC on which it is
run. | The only devices that the
program interacts with is
the PC on which it is run
and the printer associated
with the PC. | Equivalent |
| Where used | Used by physicists to
investigate new
radiopharmaceuticals,
and estimate patient
doses. Used in
universities,
pharmaceutical
manufacturing firms,
government agencies,
hospitals and research
facilities. | Used by physicists to
investigate new
radiopharmaceuticals, and
estimate patient doses.
Used in universities,
pharmaceutical
manufacturing firms,
government agencies
hospitals and research
facilities. | Equivalent |
| Standards met | None | None | Equivalent |

8

9

Summary of comparison

CDI3 and OLINDA/EXM are both computer software programs that estimate the radiation dose received by tissues in average body models. OLINDA/EXM does not estimate a "cancer detriment index", as this was deemed to be outside the scope of the program's application. OLINDA/EXM does, however, calculate equivalent dose via application of radiation weighting factors currently recommended by the ICRP (ICRP 1991). These radiation weighting factors may be modified by the user if desired. Evaluation of risk is left to the user, through application of risk models. This is not treated in OLINDA/EXM in any way.

They both use Monte Carlo based calculations and require input related to the radiation delivery method. Both programs produce tables of tissue doses. The calculation undertaken is different because the radiation source is different. The utility of OLINDA/EXM is approximately equivalent to that of the CDI3 program because the calculations for both programs are based on current scientific best practice as determined by respectively the MIRD Committee (Medical Internal Radiation Dose Committee) and the FDA. The decay data and

10

dose factors used in the OLINDA/EXM code have been extensively peer reviewed. The decay data were published in the Health Physics Journal in 2002 (Stabin and da Luz 2002), and currently may be viewed through the Health (Stable Society web site. The dose factors were then published in the Health Physics Journal in 2003 (Siegel and Stabin 2003). The phantoms on which the r nyales our are based have been established previously in the literature (Cristy dose ractors and base base al. 1995) and have been widely accepted and une ablishe international dosimetry community. Both programs are limited in that they use average body models and thus are not representative of any charticular patient. OLINDA/EXM has more body models to choose from and also permits the user to vary the mass of individual organs to provide a limited measure of patient-specificity. Both programs are intended to be used by medial c or speropriately trained physicians or equivalent in research or hospital facilities. Both programs need trained professional personnel to of nospitale program, provide the appropriate input and interpret the results.

References

Cristy M. and Eckerman K. Specific absorbed fractions of energy at various ages from internal photons sources. ORNL/TM-8381 V1-V7. Oak Ridge National Laboratory, Oak Ridge, TN; 1987.

International Commission on Radiological Protection. 1990 Recommendations of the International Commission on Radiological Protection. ICRP Publication 60, Pergamon Press, New York, 1991.

Loevinger R, Budinger T, Watson E: MIRD primer for absorbed dose calculations. Society of Nuclear Medicine; 1988.

Peterson LE and Rosenstein M. Computer program for tissue doses in diagnostic radiology. Food and Drug Administration, Center for Devices and Radiological Health, Rockville, MD 1989.

Rosenstein, M. HEW Publication FDA 76-8030, Food and Drug Administration, Rockville, Maryland. 1976.

Stabin M. MIRDOSE - the personal computer software for use in internal dose assessment in nuclear medicine. J Nucl Med, 37:538-546; 1996.

Stabin MG, da Luz CQPL. New decay data For internal and external dose assessment, Health Phys. 83(4):471-475, 2002.

Stabin MG and Siegel JA. Physical Models and Dose Factors for Use in Internal Dose Assessment. Health Physics, 85(3):294-310, 2003.