(222 days)
No
The device description focuses on physical components for patient positioning and immobilization, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device components are designed to assist in positioning and immobilizing patients during radiation therapy, but they do not directly provide therapy or affect a therapeutic change in the patient.
No
The device is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components made from materials like polyurethane foam, carbon fiber/epoxy, vinyl coated nylon, and polystyrene beads, which are physical devices used for patient positioning and immobilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment." This describes a device used on a patient for a medical procedure (radiation therapy), not a device used to examine specimens from the body (in vitro).
- Device Description: The descriptions of the various components (immobilization systems, couch overlays, positioning boards, foam, vacuum cushions, indexing bars) all relate to physical devices used to position and stabilize a patient. None of them involve the analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids/samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is clearly intended for external use on a patient during radiation therapy procedures.
N/A
Intended Use / Indications for Use
CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments.
Product codes
IYE
Device Description
The CDR Systems Precision Patient Positioning System consists of several options that may be purchased individually or as a complete system.
-
The CDR Systems Freedom SBRT Immobilization System is designed to provide an easy to use means to immobilize, position and reposition patients undergoing stereotactic radiation therapy. The SBRT Immobilization System is manufactured from Vinyl skinned flexible polyurethane foam and carbon fiber/epoxy components.
-
The CDR Systems Couch Overlay and Couch Extension are manufactured from carbon fiber/epoxy over a foam core providing a rigid radio-translucent platform to immobilize and position the Head, Neck and Shoulders of a patient.
-
The CDR Systems Belly Board System has a generally rectangular contour with a firm base that provides patient support and locations for softer modules that provide additional support for a patient's pelvis and head. The indexing bars ensure secure fixation of the Belly Board to the treatment couch.
-
The CDR Systems Prone Breast Patient Positioning System is generally rectangular in shape with firm base and soft cushions with a specific location for, pelvis, head and breasts. An interchangeable left or right contra-lateral breast support provides support for the breast not requiring radiation treatment. The breast opposite to the contralateral breast is intentionally unsupported and is allowed to hang providing unobstructed treatment access.
-
The CDR Systems Prone Head and Neck Immobilization System is a headboard that attaches to a base plate that locates onto a couch tabletop, onto a Couch Overlay or Couch Extension and provides adjustable positive and negative tilt for patient's head. The Prone Head and Neck Immobilization System can be used for support of a patient's head in supine or prone position.
-
The CDR Systems InstaForm Foam is designed to provide an easy to use means to stabilize, position and reposition patients undergoing radiation therapy on a treatment couch. Shortly after the foam has completed expanding inside a plastic bag it becomes rigid, resulting in a customized mold of the patient's anatomy for accurate positioning and stabilization for subsequent patient setups requiring the same initial position.
-
The CDR Systems Vacuum Cushion is constructed from vinyl coated nylon material that is filled with small polystyrene beads to immobilize the patient. Once evacuated, the Vacuum Cushion holds a rigid shape over the course of a specific patients radiation therapy treatment.
-
The CDR Systems Indexing Bar is designed for the indexing of patient immobilization devices onto a treatment couchtop.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head, Neck, Shoulders, Pelvis, Breast, Thigh, Calves, Knees, Feet, Torso
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench testing was performed as indicated in "Performance Testing - Bench (Tab 12)" to show that CDR devices attenuate a 6 MeV radiation beam by less than 3%.
Key Metrics
Not Found
Predicate Device(s)
K100691, K050701, K040773, K030051
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K122888
Page 1 of 9
Attachment 3
APR 3 0 2
ems
Viou AR Canada T1 21 950-7025 Ev. 14021
September 11. 2012
Tab 5 Revised 01/10/13
510{k} Summary
Manufacturer's Name: Address:
CDR Systems, Inc. #33, 235105 Wrangler Drive S.W. Calgary, Alberta, Canada T1X OK3
Corresponding Official: Title: Telephone: Fax:
Carl Denis CEO 403-850-7035 403-271-0201
Trade Name:
Common Name:
Classification Name:
Accessory to Medical Linear Accelerator, 90IYE, and Accessory to Medical Charded Particle Radiation Therapy System, 90LHN, (per 21 CFR section 892,5050)
CDR Systems Precision Patient Positioning System
Radiation therapy patient positioning devices
Predicates:
Bionix Development Corporation K100691: Omni V SBRT Positioning System K050701: Thigh and Foot Positioner. SuProne Plus K040773: Pelvis BellyBoard Plus Patient Positioning System, SecureFoam System, SecureFit Bar K030051: Versaboard Patient Positioning System
Civco Medical Solutions K111340: MR Patient Positioning Devices
Device Description: The CDR Systems Precision Patient Positioning System consists_ of several options that may be purchased individually or as a complete system.
- The CDR Systems Freedom SBRT Immobilization System is designed to provide an easy to use means to immobilize, position and reposition patients undergoing stereotactic radiation therapy. The SBRT Immobilization System is
1
manufactured from Vinvl skinned flexible polyurethane foam and carbon fiber/epoxy components.
-
The CDR Systems Couch Overlay and Couch Extension are manufactured from carbon fiber/epoxy over a foam core providing a rigid radio-translucent platform to immobilize and position the Head, Neck and Shoulders of a patient.
-
The CDR Systems Belly Board System has a generally rectangular contour with a firm base that provides patient support and locations for softer modules that provide additional support for a patient's pelvis and head. The indexing bars ensure secure fixation of the Belly Board to the treatment couch.
-
The CDR Systems Prone Breast Patient Positioning System is generally rectangular in shape with firm base and soft cushions with a specific location for, pelvis, head and breasts. An interchangeable left or right contra-lateral breast support provides support for the breast not requiring radiation treatment. The breast opposite to the contralateral breast is intentionally unsupported and is allowed to hang providing unobstructed treatment access.
-
The CDR Systems Prone Head and Neck Immobilization System is a headboard that attaches to a base plate that locates onto a couch tabletop, onto a Couch Overlay or Couch Extension and provides adjustable positive and negative tilt for patient's head. The Prone Head and Neck Immobilization System can be used for support of a patient's head in supine or prone position.
-
The CDR Systems InstaForm Foam is designed to provide an easy to use means to stabilize, position and reposition patients undergoing radiation therapy on a treatment couch. Shortly after the foam has completed expanding inside a plastic bag it becomes rigid, resulting in a customized mold of the patient's anatomy for accurate positioning and stabilization for subsequent patient setups requiring the same initial position.
-
The CDR Systems Vacuum Cushion is constructed from vinyl coated nylon material that is filled with small polystyrene beads to immobilize the patient. Once evacuated, the Vacuum Cushion holds a rigid shape over the course of a specific patients radiation therapy treatment.
-
The CDR Systems Indexing Bar is designed for the indexing of patient immobilization devices onto a treatment couchtop.
Intended Use: CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments.
Performance Testing - Bench (Tab 12) indicates that CDR devices attenuate a 6 MeV radiation beam by less than 3%.
2
Technological Characteristics: See the attached Predicate Comparison Table
| # | Feature | Predicate Device(s):
Bionix
Omni V SBRT Positioning
System - Whole Body
Stereotactic Immobilizer | Device(s):
CDR Systems Freedom SBRT
Immobilization System
with Compression Bridge,
Arms Down Module and
Arms Up Module |
|---|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | For positioning and
repositioning patients
undergoing radiation therapy | For positioning and
repositioning patients
undergoing radiation therapy |
| 2 | Classification | Class II (K100691 - Bionix) | Class II |
| 3 | Features | Has several components
designed to work together to
provide an easy to use means of
reproducing the position of a
patient undergoing external
beam Stereotactic radiation
therapy. Locates onto an
attachment bar for location on
treatment couch. Integrated rails
for attaching other components
of the system including breath-
suppression and fiducial arches. | Designed to be used to position
and immobilize the patient's
head, neck and shoulders. The
immobilization system locates
onto treatment couch using an
indexing bar. The SBRT system
has same head and neck features
as the Overlay and Extension
with the addition of molded-in
attachment points to locate other
components of the system,
including a compression bridge.
The system has various modules
that are combined to easily
setup patients for specific
techniques of treatment
including an arms up position,
an arms down position using the
Arms Up module or Arms
Down Hand Positioning
Module, and a contoured shape
location of a vacuum cushion-
type body immobilizing support.
The SBRT system is designed to
function with both the Knee/Leg
Module and Foot positioning
Module. |
| 4 | Material 1 | Acrylic/PVC Carbon
fiber/epoxy laminate material | Carbon fiber/epoxy laminate
material with foam core |
| 5 | Material 2 | Civco K111340
MR Kevlar | MR Safe - Kevlar/epoxy
laminate material with foam
core |
| # | Feature | Predicate Device(s):
Bionix
Thigh Bolster and
Foot Positioner
(Comfort Hold™) | CDR Device(s):
CDR Systems Leg/Knee
positioning module,
Indexable foot positioning
module, wedges supports
and positioning aids |
| 1 | Intended Use | For positioning and
repositioning patients
undergoing radiation therapy in
supine or prone position | For positioning and
repositioning patients
undergoing radiation therapy, in
supine or prone position |
| 2 | Classification | Class II (K050701 - Bionix) | Class II |
| 3 | Features | Designed to be used together as
a combined thigh and foot
support or alone as a foot or
thigh and calve support. Also
will interface with Bionix
secure bar allowing it to be
secured to the treatment couch. | Designed to provide support and
positioning of a patient's thigh,
calves, knees and feet. Each can
be used alone or in combination
with each other (knee and foot
positioner). A variety of shapes
are offered to optimize patient
setup and comfort. Regardless
of shape used, the purpose for
use identical. Can be used free
on couchtop surface or indexed
using indexing bar allowing it to
be indexed on treatment couch. |
| 4 | Material | ABS Plastic | MR Safe - ABS plastic, foam
with vinyl cover. |
| 5 | Beam Attenuation | Minimal beam attenuation | Minimal beam attenuation |
| # | Feature | Predicate Device(s): | CDR Device(s): |
| 1 | Intended Use | For positioning and
repositioning patients
undergoing radiation therapy in
supine and prone position | For positioning and
repositioning patients
undergoing radiation therapy, in
supine and prone position |
| 2 | Classification | Class II (K030051 - Bionix) | Class II |
| 3 | Features | Generally torso shaped in
contour with an area
specifically designed for head,
shoulders and back. Allows for
prone as well as supine
positioning of patient. Simple
interlock device to locate to
couch tabletop and others to
locate low-melt thermoplastic to
be formed into a mask that
contours the patient. | Generally torso shaped in
contour and designed to position
patient's head, neck and
shoulders and a simple fixation
device for patient specific low
temperature thermoplastic mask
that contours the patient and
simple fixation device for
Shoulder Depression. Positions
onto treatment couch with the
extension interface at end of
treatment couch provides an
integrated pitch adjustment
knob allowing for correction for
couch sag. Provides a platform
for both prone and supine
patient position. Roll adapter
module provides Roll axis of
adjustment. |
| 5 | Material 1 | Carbon fiber/epoxy laminate
material with foam core | Carbon fiber laminate material
with foam core and aluminum
base |
| 6 | Material 2 | Civco K111340
MR Kevlar | Kevlar/epoxy laminate material
with foam core and aluminum
base |
| 7 | Beam Attenuation | Minimal beam attenuation | Minimal beam attenuation |
| | | Bionix
VersaBoard Patient Positioning
System | CDR Systems Couch Overlay,
Couch Extension with
Shoulder Depression and
Roll adjustment couch
extension adapter |
| # | Feature | Predicate Device(s):
Bionix
Pelvis BellyBoard Plus Patient
Positioning System | CDR Device:
CDR Systems Koilia-Mikros
Belly Board and Prone
Breast Patient Positioning
System |
| 1 | Intended Use | For positioning and
repositioning of patients
receiving radiation therapy. | For positioning and
repositioning of patients
receiving radiation therapy. |
| 2 | Classification | Class II (K040773 - Bionix) | Class II |
| 3 | Features | A generally rectangular contour
with rigid base and specific
location for head abdominal and
leg cushions | A generally rectangular contour
with firm base and soft cushions
with specific location for, pelvis,
head and breast, a contra-lateral
breast support with through
opening to allow treatment side
breast to hang unobstructed. |
| 4 | Material | Thermoplastic shell with foam
core base with Velcro attachable
cushions for head abdomen and
legs | Thermoplastic shell with foam
core base / Firm cushion base
with Velcro attachable cushions
for head abdomen and hips and
legs. |
| 5 | Beam Attenuation | Minimal beam attenuation | Minimal beam attenuation |
Predicate Device Comparison Table
3
: :
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
4
:
.
100 - 100 -
5
and the control control control control control of the control of the controlled
:
6
| # | Feature | Predicate Device(s):
Bionix
SuProne Plus | CDR Device:
CDR Systems Prone Head and
Neck Immobilization
System |
|---|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | For positioning and
repositioning of patients
receiving radiation therapy. | For positioning and
repositioning of patients
receiving radiation therapy. |
| 2 | Classification | Class II (K050701 - Bionix) | Class II |
| 3 | Features | A headboard that affixes to a
base plate that can be secured to
a couch tabletop or VersaBoard
(as shown in Bionix catalog)
and provides an adjustable tilt
for patient's head. Can be used
for support of a patient's head
in supine or prone position. | A headboard that attaches to a
base plate that locates onto a
couch tabletop, onto a CDR
Couch Overlay or Couch
Extension and provides
adjustable positive and negative
tilt for patient's head. Can be
used for support of a patient's
head in supine or prone position.
A low temperature
thermoplastic mask can be used
for additional immobilization. |
| 4 | Material 1 | Optional acrylic base, Carbon
fiber/epoxy laminate material
with foam core | Carbon fiber/epoxy laminate
material with foam core |
| 5 | Material 2 | Civco K111340
MR Kevlar | MR Safe - Kevlar/epoxy
laminate material with foam
core |
| 6 | Beam Attenuation | Minimal beam attenuation | Minimal beam attenuation |
،
| # | Feature | Predicate Device(s):
Bionix
SecureFoam | CDR Device:
CDR Systems InstaForm Foam |
|---|------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| 1 | Intended Use | For positioning and re-
positioning of patients receiving
radiation therapy. | For positioning and re-
positioning of patients receiving
radiation therapy. |
| 2 | Classification | Class II (K040773 -Bionix) | Class II |
| 3 | Method | Mix A part (diisocyanate) with
B (polyol) to form water blown
foam | Mix A part (diisocyanate) with
B (polyol) to form water blown
foam |
| 4 | Barrier | Plastic bag | Plastic bag or plastic Sheet |
| 5 | Common Name | 2 part foaming agent | 2 part foaming agent |
| 6 | Beam Attenuation | Air-equivalent radiolucency,
minimal beam attenuation | Air-equivalent radiolucency,
minimal beam attenuation |
and the comments of the country
,
:
7
| # | Feature | Predicate Device(s):
Bionix SecureVac
Immobilization System | CDR Device:
CDR Systems Vacuum
Cushion |
|---|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | Designed to be used for the
positioning and repositioning
of patients for receiving
radiation therapy | Designed to be used for the
positioning and repositioning
of patients for receiving
radiation therapy |
| 2 | Classification | Class II (K040773 - Bionix) | Class II |
| 3 | Method | SecureVac bags are
constructed from strong, vinyl
coated nylon material that is
filled with small polystyrene
spheres to immobilize the
patient. Each bag is double
sealed airtight and fitted with
a self-closing valve for ease
of use. It also features a pinch
clamp system for more
security. Once evacuated,
the SecureVac cushion holds
a rigid shape over the
course of the radiation
therapy treatment
regimen | The CDR Systems Vacuum
Cushion is constructed from
vinyl coated nylon material
that is filled with small
polystyrene beads to
immobilize the patient.
Each bag is sealed airtight
and fitted with a self-closing
valve. Once evacuated, the
Vacuum Cushion holds a
rigid shape over the course
of a specific patients
radiation therapy treatment. |
| 4 | Material | Vinyl-coated nylon material
that is filled with small
polystyrene spheres | MR Safe - Vinyl-coated
nylon material that is filled
with small polystyrene
spheres |
| 5 | Beam Attenuation | Air-equivalent radiolucency | Air-equivalent radiolucency |
.
.
- The state of the state
and the control control control control controllers and
8
K122888
Page 9 of 9
| # | Feature | Predicate Device(s): | CDR Device: |
|---|---|---|---|
| 1 | Intended Use | Bionix SecureFit Bar | |
| For the indexing of patient | |||
| immobilization devices to | |||
| treatment couchtop | CDR Systems Indexing Bar | ||
| For the indexing of patient | |||
| immobilization devices to | |||
| treatment couchtop | |||
| 2 | Classification | Class II (K040773 - Bionix) | Class II |
| 3 | Method | Located onto treatment | |
| couch using location pins on | |||
| bottom of bar that interface | |||
| with a treatment couches | |||
| features designed to accept | |||
| and with pins on the | |||
| surface that interface with | |||
| patient immobilization device | |||
| such as a Belly Board | Located onto a treatment | ||
| couch using location pins on | |||
| the bottom of the Indexing | |||
| Bar that interface with a | |||
| treatment couch and also with | |||
| pins on the surface that | |||
| interface with patient | |||
| immobilization device such as | |||
| a Belly Board | |||
| 4 | Material 1 | Aluminum or carbon | |
| fiber/epoxy laminate | |||
| material | Aluminum or carbon | ||
| fiber/epoxy laminate | |||
| material | |||
| 5 | Material 2 | Civco K111340 | |
| MR Kevlar | MR Safe - Kevlar/epoxy | ||
| laminate material | |||
| 6 | Beam Attenuation | Aluminum is not intended to | |
| be in the beam while carbon | |||
| fiber or Kevlar /epoxy | |||
| laminate material is | |||
| acceptable if required to be in | |||
| the path of the beam. |
The CDR Systems Precision Patient Positioning System has the same intended use and safety characteristics as the comparable predicate devices.
9
Image /page/9/Picture/0 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 an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30. 2013
CDR Systems, Inc. % Mr. Carl Denis CEO #33, 235105 Wrangler Drive S.W. Calgary, Alberta, CANADA TIX OK3
Re: K122888 .
Trade/Device Name: CDR Systems Precision Patient Positioning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: March 25, 2013 Received: April 2, 2013
Dear Mr. Denis:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
10
Page 2 - Mr. Carl Denis
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known): K122888
Device Name:
CDR Systems Precision Patient Positioning System
Indications for Use:
CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments. Place a clean sheet over the device to ensure a clean device from patient to patient.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K122888
Page 1 of ____________________________________________________________________________________________________________________________________________________________________