Who is the manufacturer of CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM?

Cdr Systems, Inc. filed the 510(k) submission for CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM (K122888).

What is the FDA product code for CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM?

IYE. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM?

Bionix Omni V SBRT Positioning System (K100691); Bionix Thigh and Foot Positioner (K050701); Bionix Pelvis BellyBoard Plus Patient Positioning System (K040773); Bionix SecureFoam System (K040773); Bionix SecureFit Bar (K040773); Bionix Versaboard Patient Positioning System (K030051); Civco MR Patient Positioning Devices (K111340).

Who can help prepare an FDA 510(k) submission like CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

K122888 · Cdr Systems, Inc. · IYE · Apr 30, 2013 · Radiology

Device Facts

Record ID	K122888
Device Name	CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM
Applicant	Cdr Systems, Inc.
Product Code	IYE · Radiology
Decision Date	Apr 30, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2

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.

Device Story

CDR Systems Precision Patient Positioning System comprises modular immobilization and positioning components for radiation therapy. Components include SBRT immobilization system, couch overlays/extensions, belly boards, prone breast positioning systems, head/neck immobilization systems, expandable foam (InstaForm), vacuum cushions, and indexing bars. Devices are constructed from vinyl-skinned flexible polyurethane foam, carbon fiber/epoxy, Kevlar/epoxy, and ABS plastic. System components are placed on treatment couches to stabilize patient anatomy (head, neck, shoulders, pelvis, breast, limbs) during simulation and treatment. Indexing bars ensure secure fixation to the couch. Devices provide rigid, radio-translucent platforms or customized molds to maintain patient position, reducing movement and improving treatment accuracy. Used in clinical radiation oncology settings by radiation therapists/physicians. Benefits include reproducible patient positioning, enhanced immobilization, and minimal beam attenuation, facilitating precise radiation delivery.

Clinical Evidence

Bench testing only. Performance testing demonstrated that CDR devices attenuate a 6 MeV radiation beam by less than 3%. No clinical data provided.

Technological Characteristics

Materials: Carbon fiber/epoxy laminate, Kevlar/epoxy laminate, vinyl-skinned polyurethane foam, ABS plastic. Form factor: Modular positioning components (overlays, boards, cushions, indexing bars). Connectivity: None (mechanical). Sterilization: Not specified (intended for use with clean sheets). Beam attenuation: Minimal (<3% at 6 MeV).

Indications for Use

Indicated for patients undergoing radiation therapy or radiosurgery simulation and treatment (electron, photon, or proton). No specific age or gender restrictions.

Regulatory Classification

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.

Predicate Devices

Bionix Omni V SBRT Positioning System (K100691)
Bionix Thigh and Foot Positioner (K050701)
Bionix Pelvis BellyBoard Plus Patient Positioning System (K040773)
Bionix SecureFoam System (K040773)
Bionix SecureFit Bar (K040773)
Bionix Versaboard Patient Positioning System (K030051)
Civco MR Patient Positioning Devices (K111340)

Submission Summary (Full Text)

{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. 1. 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. 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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 | . . 1. 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 ____________________________________________________________________________________________________________________________________________________________________

CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

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CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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