The Siemens Symbia Intevo Bold is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; Planar imaging, and tomographic imaging for isotopes with energies up to 588 keV.

CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles.

SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

Software: the syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT and other imaging modalities.

Device Description

The Siemens Symbia Intevo Bold consist of Sinqle Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. The CT component produces 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. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as standalone diagnostic imaging devices.

Symbia Intevo Bold implements software version syngo MI Applications VB20A.

Modifications include:

Incorporation of the commercially available SOMATOM Scope Power CT system (K151749)
Software updates include modifications to support features available with the CT and SPECT subsystems
Expansion of commercially available xSPECT Quant (Symbia 5.0 K131634) to support quantification of additional isotopes
Four additional touchpad sensors to cover detectors' light rails and L-arms.

Commercially available xSPECT Quant (Symbia 5.0 K131634) was expanded to support quantification of additional isotopes such as I-123 and In-111. For these isotopes, dose calibrator independent quantification is enabled by a NIST traceable sensitivity calibration method. In addition, cross calibration capabilities were added to remove dose calibrator biases and variations in SUV calculations. The system allows cross calibration of multiple dose calibrators and, once calibrated, automatically adjusts for their biases.

In addition to dose calibrator independent quantification for I-123 and In-111 support for dose calibrator dependent quantification was added for a broad range of SPECT isotopes and collimators (Broad Quantification). Dose calibrator dependent quantification neither supports NIST traceable calibration nor cross calibration and relies on sensitivity measurements based on a local dose calibrator.

AI/ML Overview

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents primarily focus on the quantitative accuracy and reproducibility of the "xSPECT Quant" and "Broad Quantification" features within the Symbia Intevo Bold system.

Feature / Metric	Acceptance Criteria	Reported Device Performance
xSPECT Quant (Quantitative Accuracy)	Quantitative error <= 10% in reference to NIST	All tested isotope-collimator combinations (Tc99m-LEHR, Tc99m-LPHR, I123-LPHR, I123-MELP, In111-MELP) met the criterion.
Broad Quantification (Reproducibility)	Reproducible within <= 10%	All tested isotope-collimator combinations (Ga67-MELP, I131-HE) met the criterion.

Additionally, general performance testing against NEMA NU-1:2012 standards was conducted, with a general statement that "All Performance testing met the predetermined acceptance values." This includes intrinsic spatial resolution, intrinsic spatial linearity, intrinsic energy resolution, intrinsic flood field uniformity, multiple window spatial registration, intrinsic count rate performance in air, system spatial resolution with LEHR, SPECT reconstructed spatial resolution, intrinsic flood field uniformity at 25% busy time, intrinsic energy resolution at 25% busy time, energy peak position stability, and system spatial resolution at 25% busy time.

2. Sample Size Used for the Test Set and Data Provenance

The documents do not specify the sample size in terms of number of patient cases or images for either the quantitative accuracy or reproducibility testing. The tests utilized "phantoms."

Data Provenance: The data provenance is not explicitly stated as retrospective or prospective patient data. Given the use of "phantoms," the data is synthetically generated and controlled within a laboratory setting, not derived from human subjects. The testing was conducted by Siemens Medical Solutions USA, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The ground truth for xSPECT Quant accuracy was established directly through reference to the National Institute of Standards and Technology (NIST) traceable precision sources for calibration. For reproducibility, the ground truth standard is the initial measurement against which subsequent measurements are compared. These methods do not inherently require human expert consensus for establishing the ground truth values.

4. Adjudication Method for the Test Set

An adjudication method is not applicable and not mentioned. The quantitative accuracy and reproducibility tests rely on direct comparison to known physical standards (NIST traceable sources) or statistical measures of variance, rather than human interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned and likely not performed for this submission. The device (Symbia Intevo Bold) is an imaging system, not an AI-assisted diagnostic software in the sense of providing automated interpretations or workflow enhancements to human readers that would be typically evaluated in an MRMC study focused on reader performance improvement. The "MI Applications software" is a "display and analysis package" to aid clinicians in assessment and quantification, but the provided studies do not evaluate its impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance testing described for "xSPECT Quant" and "Broad Quantification" falls under a standalone (algorithm only) evaluation. The system's ability to accurately quantify isotopes or reproduce measurements is tested intrinsically, separate from a human operator's diagnostic interpretation. The NEMA NU-1:2012 testing also evaluates the physical performance of the SPECT and CT components in a standalone manner.

7. The Type of Ground Truth Used

xSPECT Quant (Quantitative Accuracy): The ground truth was based on a NIST traceable precision source. This is a highly accurate, objectively verifiable physical standard.
Broad Quantification (Reproducibility): The ground truth for reproducibility essentially refers to the initial, measured values from dose calibrator dependent quantification against which subsequent measurements are compared for consistency.

8. The Sample Size for the Training Set

The documents do not provide information regarding a "training set" sample size. The Symbia Intevo Bold is a medical imaging system, and while it includes software (syngo MI Applications), the described testing focuses on the physical and quantitative performance of the imaging hardware and associated quantification algorithms, not a machine learning model that would typically have a distinct training set. The software updates mention "modifications to support features" and "software improvements," suggesting iterative development rather than a single distinct training phase for a new AI model.

9. How the Ground Truth for the Training Set Was Established

Since no specific "training set" for a machine learning model is mentioned, details on how its ground truth was established are not provided. If the software components involve internal calibration or optimization routines, these would use internal reference data, but it's not discussed in the context of an external, validated training set as one might find for a deep learning algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines beneath them, creating a sense of movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2017

Siemens Medical Solutions, USA, Inc. % Ms. Cynthia Busch Regulatory Affairs Specialist 2501 N. Barrington Road HOFFMAN ESTATES IL 60192

Re: K162483

Trade/Device Name: Symbia Intevo Bold Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: November 28, 2016 Received: November 29, 2016

Dear Mr. Busch:

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.

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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.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162483

Device Name Symbia Intevo Bold

Indications for Use (Describe)

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)
----------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------

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510(k) Summary

as required by 21 CFR Part 807.87(h) and 21 CFR Part 807.92(c)

Identification of the Submitter
Submitter:	Cynthia BuschRegulatory Technical SpecialistSiemens Medical Solutions USA, Inc.2501 N. Barrington RoadHoffman Estates, IL 60192USA
Name / Address of Manufacturer:	Siemens Medical Solutions USA, Inc.Molecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Telephone Number:	(847) 304-7095
Fax Number:	(847) 304-6023
Date of Submission:	September 2, 2016
Identification of the product
Device Proprietary Name:	Symbia Intevo Bold
Common Name:	Single-photon emission computed tomography (SPECT)system
Classification Name:	Emission Computed Tomography per 21 CFR 892.1200Computed Tomography X-Ray System per 21 CFR 892.1750
Product Code:	KPS and JAK
Classification Panel:	Radiology
Class:	II

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Marketed Devices to which Equivalence is claimed

Predicate:

Device Proprietary Name:	Symbia Intevo 16
Manufacturer:	Siemens Medical Solutions USA, Inc.
Classification Name:	Emission Computed Tomography per 21 CFR 892.1200Computed Tomography X-Ray System per 21 CFR 892.1750
Product Code:	KPS and JAK
Device Class:	II
510(k) Number:	K142006

Reference Device(s):

Device Name(s):	SOMATOM Scope Power (with SOMARIS/5 VC30)
Manufacturer:	Siemens Medical Solutions USA, Inc.
Classification Name:	Computed Tomography X-Ray System per 21 CFR 892.1750
Product Code:	JAK
Device Class:	II
510(k) Number(s):	K151749

Reference Device(s):

Device Name(s):	Symbia 5.0
Manufacturer:	Siemens Medical Solutions USA, Inc.
Classification Name:	Emission Computed Tomography per 21 CFR 892.1200Computed Tomography X-Ray System per 21 CFR 892.1750
Product Code:	KPS and JAK
Device Class:	II
510(k) Number(s):	K131634

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Device Description:

Symbia Intevo Bold implements software version syngo MI Applications VB20A.

Modifications include:

Incorporation of the commercially available SOMATOM Scope Power CT system (K151749)
Software updates include modifications to support features available with the CT and SPECT subsystems
Expansion of commercially available xSPECT Quant (Symbia 5.0 K131634) to support quantification of additional isotopes
Four additional touchpad sensors to cover detectors' light rails and L-arms.

Intended Use:

The Symbia Intevo Bold is a radioloqical imaqing system that combines a sinqle photon emission computed tomography (SPECT) camera system for nuclear medicine images. and a computed tomography (CT) camera system for x-ray images.

The SPECT system is intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data, and the CT system is 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. The nuclear medicine images and the x-ray imaqes

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may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (that is, distribution of radiopharmaceuticals).

The SPECT and CT portions of the system may be used independently or in combination, and may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. The SPECT and CT images may be transferred to other systems for radiation therapy planning or additional uses.

Indications for Use:

The Siemens Symbia Intevo Bold is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The imaqes produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

SPECT: To detect or imaqe the distribution of radionuclides in the body or organ, usinq the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV

CT: The CT component is 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.

SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

Technological Characteristics:

Symbia Intevo Bold is based on the commercially available Symbia Intevo 16 of the Symbia SPECT/CT scanners (K142006, Symbia 6.0). Symbia Intevo Bold incorporates the SOMATOM Scope Power CT (K151749). Updates to xSPECT quantitative software are based on the same fundamental technology of the xSPECT quantification in Symbia SPECT/CT predicate components. The SPECT detector, existinq collimators, and CT performance specifications do not chanqe between the commercially available Symbia Intevo 16 and proposed system, Symbia Intevo Bold.

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Feature /Characteristic	Proposed Device: SymbiaIntevo Bold	Predicate Device: Intevo 16	Difference
Scanner Models	Symbia Intevo Bold	Symbia Intevo 16	New model SymbiaIntevo Bold, the subjectof this 510K application
Target Population	General use	General use	Same
Tracer Support	TI-201, Xe-133, Co-57, Tc-99m, I-123, In-111, Ga-67, I-131, F-18.	TI-201, Xe-133, Co-57, Tc-99m, I-123, In-111, Ga-67, I-131, F-18	Same
Collimators	LEHS, LEAP, LEHR, LEUHR,LEFB, ME, HE, UHE, Pinhole,SMARTZOOM, LPHR	LEHS, LEAP, LEHR, LEUHR,LEFB, ME, HE, UHE, Pinhole,SMARTZOOM, LPHR	Same
Optional Pallets	Pediatric,Scintimammography,Radiation therapy	Pediatric,Scintimammography,Radiation therapy	Same
Accessories	Head Holder, Body Wrap, ArmRest, Cushions	Head Holder, Body Wrap,Arm Rest, Cushions	Same
Software Version	syngo MI Applications VB20	syngo MI Applications VB10	MI Applications upgradefor new features,updates and defect fixes.
Somaris Version(CT Software)	VC30	VC20	CT software(commercially availablefor Scope Power(K151749) upgrade dueto new features andupdates.
CT SoftwareFeatures
	CARE Dose 4D, SureView,Workstream4D, HeartView CT,syngo Care Bolus, syngoPulmo, syngo Fly through,syngo Calcium Scoring,Asynchronous Recon,Multiplanar Reconstruction(MPR), Syngo 3D SSD,FASTPlanning, FAST Spine, IRIS,Fast kV, Fast 3D Align, multi-series CTAC, SAFIRE, iMAR,IVR, SSDE	CARE Dose 4D, SureView,Workstream4D, HeartViewCT, syngo Care Bolus, syngoPulmo, syngo Fly through,syngo Calcium Scoring,Asynchronous Recon,Multiplanar Reconstruction(MPR), Syngo 3D SSD,FASTPlanning, FAST Spine, IRIS.
		Fast kV- CT featureallows the system toautomatically adaptmAs once the scankV has been set for apatient in order tokeep the rightcorrelation betweenthese scanparameters. Fast 3D Align - CTfeature whichprovides automaticcentering andaligning of thereconstructionvolumes. Multi series CT AC-enables the use ofmultiple CT scans forattenuationcorrection SAFIRE – (SinogramAffirmed IterativeReconstruction) a CTiterativereconstructionmethod which helpslower the noise andenhance sharpnessin CT images. iMAR- Metal ArtifactReduction MetalArtifactReconstructionsoftware designed toreduce metalartifacts caused bylarge and/or densemetal objects incomputedtomography images. IVR- InterleavedVolumeReconstruction usesmeasured data byreconstructingoverlapping slicesfrom up to 32 slices.This improves thespatial resolution inthe Z-direction.
Feature /Characteristic	Proposed Device: SymbiaIntevo Bold	Predicate Device: Intevo 16	Difference
AdvancedReconstruction	IQ•SPECT ReconstructionxSPECT Reconstruction	IQ•SPECT ReconstructionxSPECT Reconstruction	Same
Quantification	xSPECT Quantification (Bq/ml)Broad QuantificationPET SUV Quantification(Bq/ml)	xSPECT Quantification(Bq/ml)PET SUV Quantification(Bq/ml)	xSPECT Quantificationexpands features toinclude standardizedquantification ofisotopes In-111 andI-123 and softwareimprovements tosupport the detectors'high-count ratequantitative imaging.Broad Quantification isan expanded offering ofxSPECT Quantificationfor Tc99m fromcommercially marketedSymbia 5.0 (K131634).

Essential Characteristics Comparison with Predicate Device:

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Siemens believes that the Symbia Intevo Bold is substantially equivalent to the predicate device. There are no differences in the Indications for Use or Fundamental Technological Characteristics of the Symbia Intevo Bold as compared to the commercially available Symbia Intevo 16. Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate devices.

Performance Testing:

Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no modifications from the original FDA clearance (K151749) that affect device performance.

Each CT subsystem is tested and passes the Applicable Performance Standards prior to shipment:

· 21 CFR 1020.30 (a) Applicability
· 21 CFR 1020.30 (b)(36)(iii)-(v) Technique factors
· 21 CFR 1020.30 (b)(58)-(62) CT, Scan, Scan Time, Tomogram, Dose
· 21 CFR 1020.30 (h)(3)(vi)-(viii) Information to be provided for users
· 21 CFR 1020.33 Computed Tomography (CT) equipment
· 21 CFR 1040.10 Laser Products
· 21 CFR 1040.11 Specific purpose laser products

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Symbia Intevo Bold is designed in accordance with the 60601-1 series including all relevant collateral standards qeneral and specific (see standards table in Safety and Effectiveness section of this document).

Performance testing is conducted according to NEMA NU-1:2012 including:

intrinsic spatial resolution;
intrinsic spatial linearity -
intrinsic energy resolution; -
intrinsic flood field uniformity; -
multiple window spatial registration
intrinsic count rate performance in air; -
system spatial resolution with LEHR
-SPECT reconstructed spatial resolution
System Performance Testing at high count rates: ●
- Intrinsic flood field uniformity at 25% busy time -
- Intrinsic enerqy resolution at 25% busy time -
- -Energy peak position stability
- System spatial resolution at 25% busy time -

Testing includes image quality performance and integration testing for the new CT subsystem. All Performance testing met the predetermined acceptance values.

Broad Quantification and xSPECT Quant Testing :

The absolute quantitative accuracy of xSPECT Quant was verified in phantoms for the isotope-collimator combinations shown in Table 1. The acceptance criterion for xSPECT Quant is a quantitative error of smaller or equal to 10% in reference to the National Institute of Standards and Technology (NIST), i.e. when the system is calibrated with the NIST traceable precision source.

The reproducibility of dose calibrator dependent Broad Quantification was verified for isotope collimator combinations shown in Table 2. The reproducibility was verified to be within 10%.

Standard quality control phantoms such as the NEMA NU 2-1994 Test Phantom and the NEMA IEC Body Phantom were used for verification testing. All tests were performed using standard clinical acquisition and reconstruction protocols. All tests met specifications.

Isotope	Collimator	Acceptance:Quantitativeerror	VerificationResult
Tc99m	LEHR	<= 10%	passed
Tc99m	LPHR	<= 10%	passed
I123	LPHR	<= 10%	passed
I123	MELP	<= 10%	passed
In111	MELP	<= 10%	passed
Table 1: Quantitative accuracy verification of xSPECT Quant

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Isotope	Collimator	Acceptance:reproduciblewithin	VerificationResult
Ga67	MELP	<= 10%	passed
I131	HE	<= 10%	passed

Table 2: Verification of quantitative reproducibility

Conclusion of Performance Testing:

The quantitative error for all supported isotopes with the collimators is smaller or equal to 10%, and met the predefined acceptance criteria.

Verification and validation of Siemens systems is performed in accordance with documented procedures, design and code reviews, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.

Safety and Effectiveness:

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 risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product.

Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards.

Symbia Intevo Bold conforms to applicable FDA recognized and international IEC, ISO and NEMA standards with reqards to performance and safety as required by the respective SPECT FDA Guidance Documents. SPECT detector and CT performance is conducted according to NEMA NU1:2012, and the performance of the new device is substantially equivalent to the predicate device.

Standard
IEC 60601-1	2005 (R)2012 andC1:2009/ (R)2012
IEC 60601-1-2	2007
IEC 60601-1-3	2013
IEC 60601-1-6	2010
IEC 60601-2-28	2010
IEC 60601-2-44	2012
IEC 60825-1	2007
IEC 60950-1	2006
IEC 61223-2-6	2006
IEC 62304	2006
IEC 62366	2007

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Standard
NEMA NU-1	2012
NEMA XR-25	2010
NEMA XR-28	2013
NEMA XR-29	2013
ISO 10993-1	2009
EN ISO 14971	2012
EN ISO 13485	2012

Substantial Equivalence:

Symbia Intevo Bold is based on the commercially available Symbia Intevo 16 and has the same intended use and utilizes the same fundamental scientific technology as the predicate device. The software updates are based on predicate device features and commercially available software applications which pose no new issues of safety and / or efficacy. Siemens considers Symbia Intevo Bold to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate device.

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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 II.