The CURA CT16/ScintCare CT16 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes. The system may include signal analysis and display equipment supports, components and accessories. The system is suitable for all patients.

Device Description

The CURA CT16/ScintCare CT16 computed tomography (CT) scanner is a medical imaging device utilizing X-ray computed tomography to obtain images of the entire body. The CURA CT16/ScintCare CT16 is a high performance imaging system that uses retina Solid State Detector technology to ensure high image quality. It uses ultrafast scintillator technology and application optimized algorithm to enhance image details and integrated anti-scatter grid (ASG) and A/D technology (ASIC) to maximize SNR. It produces better image quality by innovative calibration algorithms. Efficient design of the gantry helps achieve structural stability under high G-Load and optimize the air flow to guarantee long thermal stability for wide range of ambient temperature and pleasant user experience.

The primary components of this system include the gantry, patient table, operator console and power distribution unit. Patient images are acquired, through the use of both hardware and software, via a rotating X-ray tube and detector array on the opposite side. The collected data is transmitted to the operator console for reconstruction into cross-sectional images.

The CURA CT16/ScintCare CT16 is designed for use in a controlled clinical setting, to collect X-ray images that aid in the diagnosis and treatment of various medical conditions by a physician or similarly licensed medical professional. The CURA CT16/ScintCare CT16 is intended for use by an appropriately trained or licensed professional, such as a physician, CT X-ray technician, or field service engineer. This device is restricted to sale by or on the order of a physician or similarly licensed medical professional (i.e. by prescription only).

The CURA CT16/ScintCare CT16 system is a stationary full gantry is comprised of several subsystems, including the X-ray tube, pre-patient collimator, detector array, cooling fans, power distribution unit, high voltage inverter, high voltage generator, data collection board (DCB) electronics and support electronics. The gantry is organized into two distinct sections, the stator (stationary elements) and the rotor (rotating elements). Slip rings are utilitate the transfer of electrical power and data between the gantry rotor and stator.

The CURA CT16/ScintCare CT16 system software implements many of the CURA CT16/ScintCare CT16 Whole Body system scanner. Among the functions performed by the software are:

Entering and editing protocol, patient, and scan parameter data
Initiating scans, executing scan protocols, monitoring status, and responding to faults
Collecting image data and generating image views
Image viewing (3d reconstruction, MPR, CPR, MIP)
Image analysis (ROI)
Reporting and image filming
Exporting data for external viewing or printing
Performing calibrations
Performing diagnostics
Metal artifact reduction is a capability of the system software, but is currently a future option.
Iterative reconstruction is a capability of the system software, but is currently a future option.
Dose modulation feature (imA) is a capability of the system software, but is currently a future option.

AI/ML Overview

The provided text describes a Computed Tomography (CT) X-Ray System (CURA CT16/ScintCare CT16) and its substantial equivalence to a predicate device (Siemens SOMATOM Emotion 16). The document does not detail specific acceptance criteria or a dedicated study explicitly designed to "prove" the device meets acceptance criteria in the manner of a clinical efficacy study for an AI algorithm. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through technical comparisons and compliance with relevant safety and performance standards.

However, based on the information provided, we can infer performance aspects and an evaluation approach.

Key takeaway: The document emphasizes substantial equivalence to a predicate device and compliance with safety and performance standards for CT systems, rather than presenting a performance study with acceptance criteria for a novel AI component.

Here's an attempt to extract and interpret the requested information based on the provided text, recognizing that some points might not be directly available for this type of submission:

1. Table of acceptance criteria and reported device performance:

The document doesn't present explicit "acceptance criteria" in the format of specific quantitative thresholds unique to the CURA CT16/ScintCare CT16 for a particular clinical application. Instead, it relies on demonstrating that its technical specifications are comparable to or exceed those of the predicate device, which is already deemed safe and effective. The "performance" described is largely the inherent function of a CT system and its technical specifications compared to the predicate.

Characteristic / Performance Aspect	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (CURA CT16/ScintCare CT16)
Indications for Use	Consistent with the predicate (produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from different angles and planes).	Produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes. Suitable for all patients. Includes potential for signal analysis, display equipment, patient/equipment supports, components, and accessories.
Scan Modes	Equivalent to predicate (Surview/Scout, Helical, Axial).	Scout (surview), Helical, Axial, Multi-Axial. (Compares favorably)
Gantry Aperture (bore) size	70 cm (consistent with predicate).	70 cm. (Compares favorably)
Gantry Tilt	+/- 30 degrees (consistent with predicate).	+/- 30 degrees. (Compares favorably)
Patient Supports	Included (consistent with predicate).	Included. (Compares favorably)
Patient Table Scan Range	At least 160 cm (1600 mm) (predicate's typical range).	1700 mm (170 cm). (Slightly greater, but deemed not to affect safety or efficacy).
Generator Power Rating	50 kW (consistent with predicate).	50 kW. (Compares favorably)
kVp Settings	Similar range to predicate (80, 110, 130 kV).	80, 100, 120, 140 kV. (Similar range, with 80 kVp identical, difference deemed not to affect safety or efficacy).
mA Range (step size)	Similar to predicate (20-345 mA, 1 mA steps).	10 – 420 mA (10 mA steps). (Greater range and larger step size, deemed not to affect safety or efficacy).
Focal Spot Size	Comparable to predicate (0.8 x 0.5 mm, 0.8 x 0.7 mm).	0.7 mm x 1.2 mm (small), 1.2 mm x 1.2 mm (large). (Greater, deemed not to affect safety or efficacy).
Anode Effective Heat Capacity	5 MHU (consistent with predicate).	5.3 MHU. (Slightly greater, deemed not to affect safety or efficacy).
X-ray Tube, Max Applied Power	345 mA (consistent with predicate).	420 mA. (Greater, deemed not to affect safety or efficacy).
Detectors	Solid state array, ultra-fast ceramic (UFC) (consistent with predicate).	Solid-state ultra-high speed rare earth ceramic scintillator. (Compares favorably)
Slices	16 slices (consistent with predicate).	16 slices. (Compares favorably)
Coverage	Maximum 1500 mm (consistent with predicate).	Maximum 1700 mm. (Greater, deemed not to affect safety or efficacy).
Image Quality Evaluation	Satisfactory image quality for diagnostic purposes as determined by a certified radiologist for sample images.	"Sample clinical images have been provided within the submission. The image quality has been evaluated by a certified radiologist." (Implicitly, the image quality was found acceptable.)
Safety and Effectiveness	Demonstrated by successful completion of verification and validation testing, risk management, and conformance to international standards (e.g., IEC 60601-1, IEC 61223-3-5).	"Successful completion of verification and validation testing, risk management activities and conformance to international standards." Specific standards listed include IEC 60601-1, -1-2, -2-44, -1-3, IEC 60825-1, IEC 61223-3-5, IEC 62366-1, ISO 14971, ISO 13485, and relevant CFRs.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document mentions that "Sample clinical images have been provided within the submission" for image quality evaluation. However, it does not specify the number of sample images (cases) used in this evaluation.
Data Provenance: Not explicitly stated. The document indicates that FMI Medical Systems Inc. is based in Solon, Ohio, USA, but does not provide information on the country of origin for the clinical images. It also does not specify if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: "The image quality has been evaluated by a certified radiologist." This phrasing suggests one certified radiologist performed the evaluation.
Qualifications of Experts: The expert was a "certified radiologist." No further details on years of experience or specific subspecialty are provided.

4. Adjudication method for the test set:

Not applicable or not specified. With likely only one radiologist reviewer mentioned for "sample clinical images," there would be no need for an adjudication method in the traditional sense (e.g., 2+1, 3+1). The radiologist's assessment would be the sole evaluation of the sample images provided.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported for this submission. The device is a CT scanner, not an AI-powered diagnostic aid designed to assist human readers.
Effect Size of AI Improvement: Not applicable, as this is not an AI-based diagnostic assistance device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Study: No, a standalone performance study in the context of an AI algorithm was not conducted or reported. The CURA CT16/ScintCare CT16 is a medical imaging device (CT scanner). While it has an application-optimized algorithm for image details and innovative calibration algorithms, and mentions future options for Metal Artifact Reduction and Iterative Reconstruction (which are algorithmic in nature), the submission does not present a standalone performance evaluation of these algorithms as a separate performance claim. The "device performance" refers to the entire CT system.

7. The type of ground truth used:

For the evaluation of "sample clinical images" by the certified radiologist, the "ground truth" would implicitly be the diagnostic interpretation and assessment of image quality by a human expert (the certified radiologist). There is no mention of pathology, outcomes data, or other independent forms of ground truth for these specific samples in the context of this submission. The overall ground truth for the device's safety and effectiveness relies on its performance against established engineering and medical device standards, and substantial equivalence to a predicate device.

8. The sample size for the training set:

Not applicable. This submission is for a Computed Tomography X-Ray System, not an AI/Machine Learning algorithm that requires a training set in the typical sense for image interpretation. The algorithms mentioned (application optimized, innovative calibration, future options for MAR/Iterative Reconstruction) are part of the CT system's processing, but their development (if they involved ML) is not detailed here.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/Machine Learning algorithm submission with a defined "training set" in the context of image interpretation.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

FMI Medical Systems Inc. % Paul McFeely Ouality Assurance Engineer FMI Medical Systems. Inc. 29001 Solon Rd, Unit A Solon, OH 44139

October 4, 2018

Re: K173076

Trade/Device Name: CURA 16; ScintCare CT16 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 28, 2017 Received: September 29, 2017

Dear Paul McFeely:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'Hara For

Robert A. 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) K173076

Device Name CURA CT16 ScintCare CT16

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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Section 5 - 510(k) Summary

510(k) Submitter:	FMI Medical Systems Inc.,29001 Solon Road, Unit A,Solon, Ohio 44139, USAPhone: +1 440-600-5952Email: Scott.LeMaster@fmimaging.com
Company Contact:	Scott LeMaster, Executive Vice President
Date of Submission:	September 13, 2018
510(k) Preparer:	Paul McFeelyQuality Assurance EngineerFMI Medical Systems Inc.29001 Solon Road, Unit A, Solon, Ohio 44139Phone: 440-600-5952Email: Paul.McFeely@fmimaging.com
Device Classification:
Device Name:	CURA CT16, ScintCare CT16
Regulation Name:	Computed tomography x-ray system
Review Panel:	Radiology
Product Code:	JAK
Regulation Number:	21 CFR 892.1750

Predicate Device:

Device Class:

Predicate Device:	SOMATOM Emotion 16
Predicate 510(k):	K151752
Regulation:	21 CFR 892.1750
Regulation Name:	Computed tomography x-ray system
Class:	II
Product Code:	JAK
Panel:	Radiology
Manufacturer:	Siemens Medical Solutions USA, Inc.

Device Description:

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structural stability under high G-Load and optimize the air flow to guarantee long thermal stability for wide range of ambient temperature and pleasant user experience.

The CURA CT16/ScintCare CT16 system software implements many of the CURA CT16/ScintCare CT16 Whole Body system scanner. Among the functions performed by the software are:

Entering and editing protocol, patient, and scan parameter data
Initiating scans, executing scan protocols, monitoring status, and responding to faults
Collecting image data and generating image views
Image viewing (3d reconstruction, MPR, CPR, MIP)
Image analysis (ROI)
Reporting and image filming
Exporting data for external viewing or printing
Performing calibrations
Performing diagnostics
Metal artifact reduction is a capability of the system software, but is currently a future option.
Iterative reconstruction is a capability of the system software, but is currently a future option.
Dose modulation feature (imA) is a capability of the system software, but is currently a future option.

Device Safety and Risk Management:

The CURA CT16/ScintCare CT16 system device safety and risk management activities are documented in an associated Risk Management Plan. This document defines that the system complies with the following safety standards:

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. IEC 60601-1, Medical electrical equipment
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
. IEC 60601-2-44, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC 60601-1-3, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60825-1, Safety of laser products - Part 1: Equipment classification and requirements
. IEC 61223-3-5, Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
. IEC 62366-1, Medical devices -- Part 1: Application of usability engineering to medical devices

The Risk Management Plan has also documented the assessment of risk utilizing ISO standard ISO 14971:2012, Application of Risk Management to Medical Devices. The CURA CT16/ScintCare CT16 system has been assessed and evaluated for risk, via defined Criteria for Risk Acceptability, through an approved Risk Management Matrix.

The following reference standards and guidance documents were utilized in the design and development of the CURA CT16/ScintCare CT16 system:

ISO 14971:2012, Medical devices. Application of risk management to medical devices
ISO 13485:2016, Application of quality management system for the design and manufacture of medical devices
21 CFR 820, Quality System Regulation
21 CFR 1020.33, Computed Tomography Equipment
21 CFR 1040.10, Laser Products (IEC 60825-1)
21 CFR 1020.30, Performance Standard for Diagnostic X-Ray Systems
IEC 62304, Medical Device Software – Software life cycle processes

In addition, the CURA CT16/ScintCare CT16 system software documentation has been submitted according to a moderate level of concern utilizing the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued 05/11/05).

Performance Testing:

The CURA CT16/ScintCare CT16 system was tested to ensure it functions as intended throughout the design process. The executed test documents were reviewed for accuracy and appropriateness as part of the design of the system. Additionally, evidence of dosimetric testing has been provided within this submission and was performed to ensure the allowable limits set forth by FMI Medical Systems are accurate and achievable by the system. Sample clinical images have been provided within the submission. The image quality has been evaluated by a certified radiologist.

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Indications for Use:

The CURA CT16/ScintCare CT16 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system is suitable for all patients.

Substantial Equivalence:

FMI Medical Systems Inc. is citing substantial equivalence of the CURA CT16/ScintCare CT16 System to the 510(k), K151752, Predicate Device Siemens SOMATOM Emotion 16.

Substantial Equivalence Statement:

FMI Medical Systems Inc. is citing substantial equivalence of the CURA CT16/ScintCare CT16 System to the Siemens SOMATOM Emotion 16. Regulatory citations for the SOMATOM Emotion 16 are as follows:

Predicate Device: SOMATOM Emotion 16 Predicate 510(k): K151752 Regulation: 21 CFR 892.1750 Class: II Product Code: JAK Panel: Radiology Manufacturer: Siemens Medical Solutions USA, Inc.

The CURA CT16/ScintCare CT16 System is substantially equivalent in design, intended use, indications for use and technology with the currently marketed predicate. There are no significant differences in materials, energy source, or technological characteristics. Both the proposed system and the predicate are computed tomography scanners that support visualization tools. The design and fundamental scientific technology of both systems compare favorably.

The CURA CT16/ScintCare CT16 System and the predicate both produce images of the head and body by computer reconstruction of X-ray transmission data. The subsystems (patient supports, generator, x-ray tube and detector) of both devices compare favorably, with only minor differences that do not affect safety and efficacy. This is supported by a comparison of system component characteristics and specifications in the table above.

The CURA CT16/ScintCare CT16 System is as safe and effective as the predicate device, as demonstrated by successful completion of verification and validation testing, risk management activities and conformance to international standards. It is the conclusion of FMI Medical Systems that the CURA CT16/ScintCare CT16 System is substantially equivalent to the predicate, Siemens SOMATOM Emotion 16, and that there are no significant differences that raise new issues of safety or efficacy.

Additional comparisons are listed in the table below.

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Characteristics –Components /Specifications	Predicate:SiemensSOMATOM Emotion 16	Proposed:CURA CT16/ScintCareCT16	Comments
Indications for use	The SOMATOM Emotion6/16 systems areintended to producecross-sectional imagesof the body by computerreconstruction of x-raytransmission data fromeither the same axialplane taken at differentangles or spiral planestaken at different angles.(spiral planes: the axialplanes resulted from thecontinuous rotation ofdetectors and x-ray tube,and the simultaneoustranslation of thepatient.)	The CURACT16/ScintCare CT16 isa ComputedTomography X-RaySystem that is intendedto produce cross-sectional images of thebody by computerreconstruction of X-raytransmission datacollected at differentangles and planes. Thesystem may includesignal analysis anddisplay equipment,patient and equipmentsupports, componentsand accessories. Thesystem is suitable for allpatients.	The CURACT16/ScintCare CT16proposed indications foruse are consistent withthe predicate. Bothsystems are capable ofimaging in axial andspiral planes, at multipleangles. The CURACT16/ScintCare CT16also indicates thepotential for signalanalysis and displayequipment, patient andequipment supports,components andaccessories. In addition,the CURACT16/ScintCare CT16system specifiessuitability for all patients.
Design
Scan modes	Surview (scout)HelicalAxial	Scout (surview)HelicalAxialMulti-Axial	Compares favorably
Gantry
Gantry aperture (bore)size	70 cm	70 cm	Compares favorably
Gantry tilt	+/- 30 degrees	+/- 30 degrees	Compares favorably
Patient Support / Couch / Table
Patient supports	Included	Included	Compares favorably
Patient table scan range	160 cm (1600 mm)	1700 mm (170 cm)	The CURACT16/ScintCare CT16patient table scan rangeis 10 cm longer than thepredicate. Thisdifference does notaffect safety or efficacy.
Generator power rating	50 kW	50 kW	Compares favorably
kVp settings	80, 110, 130 kV	80, 100, 120, 140 kV	kVp settings for CURACT16/ScintCare CT16(ranges from 80 to 140kVp) are similar to thepredicate (ranges from80 to 130 kVp). ForCURA CT16/ScintCareCT16, 1 of the 4 specificsettings (80 kVp) isidentical to the predicate.This does not affectsafety or efficacy.
Characteristics –	Predicate:	Proposed:	Comments
Components /	Siemens	CURA CT16/ScintCare
Specifications	SOMATOM Emotion 16	CT16
mA range (step size)	20-345 mA (1 mA steps)	10 – 420 mA (10 mAsteps)	The mA range for theCURA CT16/ScintCareCT16 (10 - 420 mA) isgreater than thepredicate (20 - 345 mA).Also, the step size of theCURA CT16/ScintCareCT16 (10 mA) is greaterthan that of the predicate(1 mA). Thesedifferences do not affectsafety or efficacy.
Focal spot size	0.8 x 0.5 mm0.8 x 0.7 mm	0.7 mm x 1.2 mm (small)1.2 mm x 1.2 mm (large)	The focal spot sizes forthe CURACT16/ScintCare CT16are greater than those ofthe predicate. Thisdifference does notaffect safety or efficacy.
Anode effective heatcapacity	5 MHU	5.3 MHU	Anode effective heatcapacity of the CURACT16/ScintCare CT16 is0.3 MHU greater thanthe predicate. Thisdifference does notaffect safety or efficacy.
X-ray tube, maximumapplied power	345 mA	420 mA	X-ray tube maximumapplied power for theCURA CT16/ScintCareCT16 is 75 mA greaterthan the predicate. Thisdifference does notaffect safety or efficacy.
Detector (DMS or Data Management System)
Detectors	Solid state array, ultra-fast ceramic (UFC)	Solid-state ultra-highspeed rare earth ceramicscintillator	Compares favorably
Slices	16 slices	16 slices	Compares favorably
Coverage	Maximum 1500 mm	Maximum 1700 mm	Coverage for the CURACT16/ScintCare CT16 is200 mm greater than thepredicate. Thisdifference does notaffect safety or efficacy.

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Regulation Number and Section

§ 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.