(15 days)
Not Found
No
The summary describes a hybrid imaging system combining existing SPECT and CT technologies with image registration and fusion capabilities. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an imaging system used for diagnosis, not for treatment.
Yes
This device combines SPECT and CT imaging to provide functional and anatomical information for accurate and comprehensive diagnoses. The output is used to localize nuclear medicine data and aid in diagnosis.
No
The device description clearly states it is a "hybrid SPECT/CT system" and describes physical components like gantries and acquisition consoles, indicating it is a hardware-based imaging system with integrated software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) outside the body. The Precedence system is an imaging system that acquires images of the human body using nuclear medicine and CT technology.
- The intended use and device description clearly state that it is an imaging system. It produces images of the distribution of radiopharmaceuticals and x-ray transmission data to visualize anatomical structures and functional processes within the body.
- There is no mention of analyzing biological samples or performing tests on specimens.
The Precedence system is a medical imaging device used for diagnostic purposes, but it falls under the category of in vivo imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Precedence is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The x-ray computed tomography subsystem may consist of a whole body multi-slice CT or cardiovascular CT. The cardiovascular subsystem provides coronary imaging that is intended to produce cross-sectional images of the heart, cardiovascular, and peripheral vascular systems by computer reconstruction of x-ray transmission data taken at difference angles and planes. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
The Precedence CV Configuration CT subsystem is only for the imaging of the cardiovascular system.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS, 90 JAK
Device Description
The Precedence SPECT/CT Imaging System is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT sequentially (dual-modality studies) wherein the SPECT and CT studies may be automatically coregistered and displayed in fused form. Because the natures of the imaging modalities, they provide different information; the SPECT study yields functional information about metabolic processes and the CT study yields structural or anatomical information. As radionuclides become more tissue specific, diagnoses from nuclear images alone will be more difficult without the general anatomical detail less specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses.
Precedence is constructed from two existing systems, the Skylight SPECT Imaging System and the Brilliance CT with subsystem options of 6, 16, or 64 slice or the CVCT configuration. The Precedence has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Precedence SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance.
Precedence is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The clinical protocols and procedures are that are available on the modified Precedence Imaging System are the same as those on the Predicate Devices Precedence SPECT/CT (cleared as Griffin) (K041218), Predicate Philips Plus CT Scanner (K033326), and the Brilliance CT, Private Practice CV configuration CT Scanner (K042293). The intended use of the CV configuration CT Scanner is limited to the heart, cardiovascular, and peripheral vascular systems. Acquired SPECT and CT images on the Precedence may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image. The Precedence CV Configuration CT subsystem is not indicated for imaging structures that are defined as non-cardiac and non-vascular (including soft tissue and bone).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single photon nuclear medicine images, x-ray computed tomography
Anatomical Site
Heart, cardiovascular, peripheral vascular systems. (Stated as not indicated for non-cardiac and non-vascular structures including soft tissue and bone).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Radiation safety by compliance and certification to the performance standards for . ionizing radiation emitting product 21 CFR 1020.30 and 21 CFR 1020.3333. The radiation safety product report will be filed in accordance with 21 CFR 1002.10 with the Center for Device and Radiological Health.
- Electrical and mechanical safety is assured as the system is designed to applicable . voluntary standards in the IEC 60601-1 series. The device performance was measured in accordance with the NEMA-NU-1 standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Precedence SPECT/CT (cleared as Griffin) (K041218), Predicate Philips Plus CT Scanner (K033326), Brilliance CT, Private Practice CV configuration CT Scanner (K042293)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Section B – Administrative Information
r051351
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information
| A. | Submitted By: | ADAC Laboratories
540 Alder Dr.
Milpitas, CA 95035 | Contact: Coleen Coleman
Tel: (408) 468-3051
Fax: (408) 468-3050 |
|----|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| B. | Device Trade Name: | Precedence SPECT/CT Imaging System | |
| | Common Name: | Single Photon Emission Computed Tomography
Computed Tomography X-Ray | |
| | Classification Name: | System, Emission Computed Tomography, (892.1200)
System, Computed Tomography X-Ray, (892.1750) | |
| | Device Class: | 21CFR 892.1200, Class II
21 CFR 892.1750, Class II | |
| | Product Code: | 90 KPS and 90 JAK | |
| C. | Date prepared: | May 6, 2005 | |
| D. | Predicate Device: | Precedence SPECT/CT (cleared as Griffin) (K041218)
Predicate Philips Plus CT Scanner (K033326)
Brilliance CT, Private Practice CV configuration
CT Scanner (K042293) | |
E. Performance Standards
- 21 CFR 1020.30 1020.33 as applicable for Ionizing Radiation Emitting . Products (Applicable Sections)
- . NEMA NU-1
F. Intended Use:
Precedence is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The x-ray computed tomography subsystems may consist of a whole body multi-slice CT or cardiovascular CT. The cardiovascular subsystem provides coronary imaging that is intended to produce cross-sectional images of the heart, cardiovascular, and peripheral vascular systems by computer reconstruction of x-ray transmission data taken at difference angles and planes. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
1
Contraindications for Use:
The Precedence CV Configuration CT subsystem is not indicated for imaging structures that are defined as non-cardiac and non-vascular (including soft tissue and bone).
- F. Device Description:
The Precedence SPECT/CT Imaging System is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT sequentially (dual-modality studies) wherein the SPECT and CT studies may be automatically coregistered and displayed in fused form. Because the natures of the imaging modalities, they provide different information; the SPECT study yields functional information about metabolic processes and the CT study yields structural or anatomical information. As radionuclides become more tissue specific, diagnoses from nuclear images alone will be more difficult without the general anatomical detail less specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses.
Precedence is constructed from two existing systems, the Skylight SPECT Imaging System and the Brilliance CT with subsystem options of 6, 16, or 64 slice or the CVCT configuration. The Precedence has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Precedence SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance.
Precedence is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The clinical protocols and procedures are that are available on the modified Precedence Imaging System are the same as those on the Predicate Devices Precedence SPECT/CT (cleared as Griffin) (K041218), Predicate Philips Plus CT Scanner (K033326), and the Brilliance CT, Private Practice CV configuration CT Scanner (K042293). The intended use of the CV configuration CT Scanner is limited to the heart, cardiovascular, and peripheral vascular systems. Acquired SPECT and CT images on the Precedence may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image. The Precedence CV Configuration CT subsystem is not indicated for imaging structures that are defined as non-cardiac and non-vascular (including soft tissue and bone).
2
Comparison to Predicate Device: G.
The modified Precedence SPECT/CT Imaging System and the Precedence predicate (K041218) are similar in that all the devices consist of a full functional SPECT and CT system. The patient may have a diagnostic SPECT and CT scan performed consecutively without having to move the patient. The Precedence provides a mean to reach the diagnostic decision faster than the conventional way of imaging patients with both SPECT and CT systems in separate locations.
The combined Precedence SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. The major difference is that the modified Precedence has added the CT subsystem options of the 64 slice and the CV configuration CT Scanner.
- H. System Performance Test:
- Radiation safety by compliance and certification to the performance standards for . ionizing radiation emitting product 21 CFR 1020.30 and 21 CFR 1020.3333. The radiation safety product report will be filed in accordance with 21 CFR 1002.10 with the Center for Device and Radiological Health.
- Electrical and mechanical safety is assured as the system is designed to applicable . voluntary standards in the IEC 60601-1 series. The device performance was measured in accordance with the NEMA-NU-1 standard.
- I. Conclusion:
The Precedence Imaging System is substantially equivalent to the predicate devices, the Precedence SPECT/CT (cleared as Griffin) (K041218), Predicate Philips Plus CT Scanner (K033326), and the Brilliance CT, Private Practice CV configuration CT Scanner (K042293) based upon similar intended use, technological comparison, and system performance.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted as a staff with a serpent entwined around it, representing healing and medicine. The seal is in black and white.
Public Health Service
JUN 8 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ADAC Laboratories, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169
Re: K051351
Trade/Device Name: Precedence SPECT/CT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: KPS and JAK Dated: May 19, 2005 Received: May 24, 2005
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have re review your boother evere is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholors) to regard ment date of the Medical Device Amendments, or to devices that have been May 20, 1970, and charment 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 do not require approval or or a provisions of the Act. The general controls provisions of the Act device, subjoct to the general registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your de roo be subject to such additional controls. Existing major regulations affecting your Approvation of 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); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin managements .
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket notification: "The PDF maing of our device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice tor your de read on the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, formation on your responsibilities under the Act from the 807.97). You may only only concretional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) NUMBER (if known):
KOS/351
DEVICE NAME: Precedence SPECT/CT Imaging System
INDICATIONS FOR USE:
Precedence is an imaging system combining the acquisition of single photon nuclear Precedence is an imaging system conforming consumed tomography system. The x-ray
medicine images and images from an x-ray computer hads multi-slice CT or medicine images and mages from an x ray to f a whole body multi-slice CT or computed tomography subsystem may consisted a movides coronary imaging that is cardiovascular CI. The cardiovascular subsystem por cardiovascular, and peripheral
intended to produce cross-sectional images of the hearsions asts taken at vascular systems by computer reconstruction of x-ray transmission data taken at vascular systems by computer reconstruction of its and annon-attenuation corrected and difference and planes. Frecedints into proceding harmaceuticals in the body as
attenuation corrected images of the can concession as area to produce well as x-ray transmission images. The CT transmission data may be used to produce well as x-ray transmission mages. The CT manimablem maker medicine images and the CT
attenuation corrected nuclear medicine images. The necicin' in the same attenuation corrected includine mings in a fused format (overlaid in the same
images may be registered and displayed in a fused formation' data for natom images may be registered and displayed in rused formatoryical data for anatomical orientation) to provide combined single procedence may be used either as a separate
localization of the nuclear medicine data. Precedence with and single photon localization of the nuclear medically data. I researce and single photos single photon system, a separate C. System or as a beatransfered to other systems such as
system. The nuclear medicine and CT images may be transfered to other systems should system. The nuclear medicine and CT integos may or acked only be used by trained healthcare professionals.
The Precedence CV Configuration CT subsystem is only for the imaging of the cardiovascular system.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Colin m. Pollard
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