(159 days)
Not Found
No
The document describes standard CT image reconstruction techniques, including iterative reconstruction (IRIS), but does not mention AI or ML. The new software features listed are related to workflow and hardware control, not AI/ML image analysis or processing.
No
The device is described as a diagnostic imaging system (X-ray computed tomography scanner) intended to produce cross-sectional images of the body, which is used for diagnosis and not for therapeutic treatment.
Yes
The device is described as producing "cross-sectional images of the body by computer reconstruction of x-ray transmission data," and the images are used for "image evaluation." The Intended Use/Indications for Use section states that the device is "intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data," which are then used for evaluation. This process of creating images to evaluate the body fits the definition of a diagnostic device.
No
The device description explicitly states that the SOMATOM Scope and SOMATOM Scope Power are "whole body X-ray computed tomography scanners," which are hardware devices. The software described (SOMARIS/5) is a component of these hardware systems, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for producing cross-sectional images of the body using X-ray transmission data. This is a diagnostic imaging procedure performed on a living patient, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description confirms it's a whole body X-ray computed tomography scanner.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a medical imaging system used for diagnostic purposes in vivo (within the living body).
N/A
Intended Use / Indications for Use
The SOMATOM Scope and SOMATOM Scope Power are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes" taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
Product codes
JAK
Device Description
The SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are whole body X-ray computed tomography scanners which operate with SOMARIS/5 software. SOMARIS/5 is a windows based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are able to transfer the acquired CT image data for image evaluation, using the DICOM standard.
New software version syngo® CT VC28 supports the addition of eCockpit, eStart, eMode, eSleep, a Table Footswitch, Adaptive Signal Boost, and Gantry tilt Speed up.
eCockpit
The SOMATOM Scope and SOMATOM Scope Power will support a marketed bundle of features designed to support more efficient usage of system tube power. These features will be marketed under the name, "eCockpit," and comprised of the following:
eMode
ECO Mode (eMode) is a software feature, which uses pre-set values to reduce tube power (mA) and increase scan time, while keeping the dose unchanged. With this reduction in tube power, tube life can be increased. There is a click button (eAdjust) to upload eMode. The usage of the ECO Mode (eMode) is recorded in the tube usage history.
eStart
eStart is a software option that extends the tube lifetime by pre-warming the tube before a scan. The system provides a recommendation to the user to perform eStart to warm up the tube each time the scanner has not been used for scanning in the last 30 minutes. This functionality helps to protect the tube and extend the tube lifetime.
eSleep
eSleep is a software option designed to save energy by stopping gantry rotation during scan breaks.
Table Footswitch
Foot Switch located on the bottom edge of the patient table allowing table lifting and lowering. Speeds up patient preparation and keeps the operator hands sterilized.
Gantry tilt Speed up
Faster gantry tilt speed helps in dealing with higher patient throughput.
IRIS
IRIS is an approach to iterative reconstruction that works to intelligently solve the trade-off between reconstruction times and image quality. In an iterative reconstruction, a correction loop is introduced into the Image generation process. To avoid long reconstruction times, IRIS is applied to raw data reconstruction only once. During this initial raw data reconstruction, a master volume is generated that contains the full amount of raw data information, but at the expense of significant image noise. The following iterative corrections are then consecutively performed in the image space, removing image noise without degrading image sharpness.
Adaptive Signal Boost
Adaptive Signal Boost amplifies low signals when high attenuation is present - such as when imaging obese patients or patients with metal implants - and further reduces streaks and noise.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray transmission data / Computed Tomography X-ray System
Anatomical Site
body
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
Non-clinical tests and phantom testing were conducted for the SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) during product development. The testing results supports that all the software specifications have met the acceptance criteria. The modifications described in this Premarket Notification were supported with verification/validation testing. Testing for verification and validation of the device was found acceptable to support the claim of substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests and phantom testing were conducted for the SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) during product development. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. The modifications described in this Premarket Notification were supported with verification/validation testing. Testing for verification and validation of the device was found acceptable to support the claim of substantial equivalence. EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify conformance to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure in profile, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2014
Siemens Medical Solutions USA, Inc. % Ms. Eve Davis Regulatory Affairs Specialist Enter consultant name here, or erase this if there is none 51 Valley Stream Parkway MALVERN PA 19355
Re: K140912
Trade/Device Name: Somatom Scope/Somatom Scope Power Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-Ray system Regulatory Class: II Product Code: JAK Dated: July 23, 2014 Received: July 24, 2014
Dear Ms. Davis:
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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Sm.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140912
Device Name SOMATOM Scope/Scope Power
Indications for Use (Describe)
The SOMATOM Scope and SOMATOM Scope Power are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes" taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are all capitalized and are a light blue color. The word is displayed horizontally and is the main focus of the image.
510(k) Summary
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: July 23, 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
-
- General Information Importer/Distributor: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Establishment Registration Number: 2240869
- General Information Importer/Distributor: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Manufacturing Site: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. 278 Zhou Zhu Rd Shanghai, CHINA 201318
Establishment Registration Number: 3003202425
2. Contact Person:
Eve Davis Regulatory Affairs Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 219-7133 Fax: (610) 448-1778 Email: eve.davis@siemens.com
3. Device Name and Classification
| Product Name: | SOMATOM Scope |
|---|---|
| Propriety Trade Name: | SOMATOM Scope |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Product Name: | SOMATOM Scope Power |
Propriety Trade Name: Classification Name: Classification Panel:
SOMATOM Scope Power Computed Tomography X-ray System Radiology
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Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The word is written in a light blue color. The background is white, which makes the word stand out.
CFR Section: Device Class: Product Code: 21 CFR §892.1750 Class II JAK
4. Substantial Equivalence:
Siemens SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (Somaris/5 VC28) are substantially equivalent to the following medical devices in commercial distribution:
| Predicate Devices | FDA Clearance
Number | FDA Clearance
Date | Product
Code |
|--------------------|-------------------------|-----------------------|-----------------|
| SOMATOM Emotion 16 | K050297 | 03/01/2005 | JAK |
| SOMATOM Spirit | K042328 | 09/14/2004 | JAK |
5. Device Description:
The SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are whole body X-ray computed tomography scanners which operate with SOMARIS/5 software. SOMARIS/5 is a windows based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are able to transfer the acquired CT image data for image evaluation, using the DICOM standard.
New software version syngo® CT VC28 supports the addition of eCockpit, eStart, eMode, eSleep, a Table Footswitch, Adaptive Signal Boost, and Gantry tilt Speed up.
eCockpit
The SOMATOM Scope and SOMATOM Scope Power will support a marketed bundle of features designed to support more efficient usage of system tube power. These features will be marketed under the name, "eCockpit," and comprised of the following:
· eMode
ECO Mode (eMode) is a software feature, which uses pre-set values to reduce tube power (mA) and increase scan time, while keeping the dose unchanged. With this reduction in tube power, tube life can be increased. There is a click button (eAdjust) to upload eMode. The usage of the ECO Mode (eMode) is recorded in the tube usage history.
· eStart
eStart is a software option that extends the tube lifetime by pre-warming the tube before a scan. The system provides a recommendation to the user to perform eStart to warm up the tube each time the scanner has not been used for scanning in the last 30 minutes. This functionality helps to protect the tube and extend the tube lifetime.
5
Image /page/5/Picture/1 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The background is white.
· eSleep
eSleep is a software option designed to save energy by stopping gantry rotation during scan breaks.
Table Footswitch
Foot Switch located on the bottom edge of the patient table allowing table lifting and lowering. Speeds up patient preparation and keeps the operator hands sterilized.
Gantry tilt Speed up
Faster gantry tilt speed helps in dealing with higher patient throughput.
IRIS
IRIS is an approach to iterative reconstruction that works to intelligently solve the trade-off between reconstruction times and image quality. In an iterative reconstruction, a correction loop is introduced into the Image generation process. To avoid long reconstruction times, IRIS is applied to raw data reconstruction only once. During this initial raw data reconstruction, a master volume is generated that contains the full amount of raw data information, but at the expense of significant image noise. The following iterative corrections are then consecutively performed in the image space, removing image noise without degrading image sharpness.
Adaptive Signal Boost
Adaptive Signal Boost amplifies low signals when high attenuation is present - such as when imaging obese patients or patients with metal implants - and further reduces streaks and noise.
6. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
The SOMATOM Scope and SOMATOM Scope Power, both configured with software version syngo® CT VC28 (SOMARIS/5 VC28), do not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices.
The differences between the legally marketed predicate devices and the SOMATOM Scope and SOMATOM Scope Power are as follows:
| Property | SOMATOM
Scope | SOMATOM
Scope Power | SOMATOM
Emotion 16 | SOMATOM
Spirit |
|------------------------------------------|---------------------------------------------|-------------------------------------------------|----------------------------------|------------------------------|
| Generator
Output// Tube
Name | 26kW/DURA
202 MV | 50kW/DURA
422 MV | 50kW/DURA
422 MV | 26kW/DURA
202 MV |
| Maximum.
number of
slices/rotation | 16 | 16 | 16 | 2 |
| # Elements//
Channels | 24x1472 | 24x1472 | 24x1472 | 2x1344 |
| Slice Thickness | 0.6-19.2 mm | 0.6-19.2 mm | 0.6-19.2 mm | 1-10 mm |
| kV-Range // mA-
Range | 80, 110, 130
kV/ 20-180MV
DURA 202 MV | 80, 110, 130
kV/ 20-345
mA DURA
422-MV | 80, 110, 130
kV/ 20-345
mA | 80, 110, 130
kV/ 20-180Ma |
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Special 510(k) Submission: SOMATOM Scope and Scope Power
| Anode Heat
Storage | 2MHU //DURA
20 | 5 MHU //
DURA 422 MV
2 MV | 5 MHU
//DURA 422
MV | 2MHU //DURA
202 MV |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Tube Focal Spot /
mm | 0.8 x 0.4 / 0.8
x 0.7// DURA
202 MV | 0.8 x 0.5 / 0.8
x 0.7// DURA
422 MV | 0.8 x 0.5 / 0.8
x 0.7 | 0.8 x 0.4 / 0.8
x 0.7// DURA
202 MV |
| Scan Times
(partial) // Subsec
(partial) | 0.8(optional);
1.0; 1.5 sec | 0.5 (optional);
0.6; 1.0; 1.5
sec | 0,5 (optional);
0.6; 1.0; 1.5
sec | 0.8, 1.0, 1.5 s |
| Topogram
(Length x Scan
Field) | 128 —1530 x
500 mm | 128 —1530 x
500 mm | 128 —1530 x
500 mm | 128 —1500 x
500 mm |
| Recon Time:
Stand. // HiRes //
Topo | Up to 6
images/s// 12
images
(optional) | Up to 8
images/s// 16
images/s
(optional) | Up to 8
images/s// 16
images/s
(optional) | Up to 5
images/s |
| LC Resolution
(20cm Catph. /
CTDIvol 32cm) | 5 mm/ 3HU/
12.54 mGy | 5 mm/ 3HU/
12.88 mGy | 5 mm/ 3HU/
12.88 mGy | 5mm/3HU/13.7
mGy (Dose at
surface) |
| CTDI (Dose/100
mAs) /
16cm Phant.
(typical head)
32cm Phant.
(typical body) | Typical
head:130kV A:
18.6 mGy B:
19.5 mGy
Typical
body:130kVA:
5.7 mGy B:
10.5 mGy | Typical
head:130kV A:
18.7mGy B:
19.6mGy
Typical
body:130kVA:
5.8mGy B:
10.9mGy | Typical
head:130kV
A: 18.7mGy B:
19.6mGy
Typical
body:130kV
A: 5.8mGy B:
10.9mGy | Typical
head:130kV
A: 19.0mGy
B: 21.3mGy
Typical
body:130kV
A: 5.8mGy B:
10.8mGy |
| Max. HC
Resolution (2%
MTF wire in
plastic) | 15.15 lp/cm | 15.15 lp/cm | 15.15 lp/cm | n.a. |
The intended use and fundamental scientific technology are similar to the predicate devices; therefore Siemens believes that they are substantially equivalent to the predicate devices.
7. Nonclinical Testing:
The SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are designed to fulfill the requirements of the following standards:
7
Special 510(k) Submission: SOMATOM Scope and Scope Power
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Standards
Development
Organization |
|-----------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------|
| 5-40 | General | Medical devices - Application of risk
management to medical devices | 14971 Second
Edition 2007-
03-01 | ISO |
| 5-41 | General | Medical electrical equipment - Part
1-4: General requirements for safety
-- Collateral standard:
Programmable electrical medical
systems, edition 1.1 | 60601-1-4:
2000 Consol.
Ed. 1.1 | IEC |
| 5-85 | General | Medical electrical equipment -- Part
1-6: General requirements for basic
safety and essential performance --
Collateral Standard: Usability | 60601-1-6
Edition 3.0
2010-01 | IEC |
| 13-8 | Software | Medical device software - Software
life cycle processes | 62304 First
edition 2006-05 | IEC |
| 12-218 | Radiology | Digital Imaging and Communications
in Medicine (DICOM) Set | PS 3.1-3.18
(2009) | NEMA |
| 12-222 | Radiology | Evaluation and routine testing in
medical imaging departments - Part
3-5: Acceptance tests - Imaging
performance of computed
tomography X-ray equipment | 61223-3-5 First
Edition 2004-
08 | IEC |
| 12-226 | Radiology | Evaluation and routine testing in
medical imaging departments - Part
2-6: Constancy tests - Imaging
performance of computed
tomography X-ray equipment | 61223-2-6
Second Edition
2006-11 | IEC |
| 12-225 | Radiology | Computed Tomography Dose Check | XR-25 | NEMA |
| 12-250 | Radiology | Medical electrical equipment - Part
2-44: Particular requirements for the
basic safety and essential
performance of X-ray equipment for
computed tomography | 60601-2-44
Edition 3.0
2012-08
Amendment 1 | IEC |
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests and phantom testing were conducted for the SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) during product development.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. The modifications described in this Premarket Notification were supported with verification/validation testing. Testing for verification and validation of the device was found acceptable to support the claim of substantial equivalence.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify conformance to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially
8
SIEMENS
equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.
8. Indications for Use:
The SOMATOM Scope and the SOMATOM Scope Power are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and xray tube, and the simultaneous translation of the patient.)
9. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
10. Conclusion as to Substantial Equivalence:
In summary, Siemens is of the opinion that the SOMATOM Scope and the SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) software package do not introduce any new potential safety risks and are substantially equivalent to and performs as well as the predicate devices.