(90 days)
No
The document describes standard image processing algorithms and does not mention AI, ML, or related concepts.
No
The device is indicated for imaging and assessment of bodily functions, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "indicated for the imaging of the distribution in the body of physiological tracer molecules labeled with positron-emitting isotopes. Such images are particularly useful in the assessment of brain function." This clearly indicates that the device produces images that are used to assess or diagnose conditions.
No
The device description clearly outlines multiple hardware components including a gantry, detector arrays, signal processing unit, data acquisition unit, patient table, and imaging workstation. While it includes image processing software, it is an integral part of a larger hardware system.
Based on the provided information, the Hamamatsu PET Scanner Model SHR-22000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "imaging of the distribution in the body of physiological tracer molecules labeled with positron-emitting isotopes." This describes an in vivo (within the living body) imaging procedure, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a PET scanner system, which is a medical imaging device used to visualize processes within the body.
- Anatomical Site: The indicated anatomical sites are "body" and "brain," further supporting its use for imaging within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue) outside the body, which is a defining characteristic of IVD devices.
Therefore, the Hamamatsu PET Scanner Model SHR-22000 is a medical imaging device used for in vivo procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution in the body of physiological tracer molecules labeled with positron-emitting isotopes. Such images are particularly useful in the assessment of brain function.
Product codes
90 KPS
Device Description
The Hamamatsu PET Scanner Model SHR-22000 is similar to previous PET scanners marketed by other companies, but it represents an increase in performance over other PET Scanners through improved resolution. The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation.
The SHR-22000 PET Scanner system consists of five main subsystems: the main gantry with the detector arrays, the signal processing unit, the data acquisition unit, the patient table and positioning sub-system, and the imaging workstation and user interface.
Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution. The gantry also has a 6Ge-6Ga source mounted in a stainless steel rod for calibration.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET
Anatomical Site
Body, brain
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
Not Found
Summary of Performance Studies
Imaging performance tests were carried out to assure equivalence of image characteristics with the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Siemens ECAT Exact HR PET scanner (K962797)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 17 1998
510(k) Summary
Hamamatsu PET Scanner Model SHR-22000
Common/Classification Name: PET Scanner, 21 CFR 892.1200
Hamamatsu Photonics, K.K. 325-6, Sunayama-cho Hamamatsu City 430 JAPAN
Contact: Keith Kobayashi, Prepared: May 18, 1998
LEGALLY MARKETED PREDICATE DEVICES A.
The Hamamatsu PET Scanner Model SHR-22000 is substantially equivalent to the Siemens ECAT Exact HR PET scanner (K962797).
DEVICE DESCRIPTION B.
ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
The Hamamatsu PET Scanner Model SHR-22000 is similar to previous PET scanners marketed by other companies, but it represents an increase in performance over other PET Scanners through improved resolution. The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation.
The SHR-22000 PET Scanner system consists of five main subsystems: the main gantry with the detector arrays, the signal processing unit, the data acquisition unit, the patient table and positioning sub-system, and the imaging workstation and user interface.
Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution. The gantry also has a 6Ge-6Ga source mounted in a stainless steel rod for calibration.
C. INTENDED USE
The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution in the body of physiological tracer molecules labeled with positron-emitting isotopes. Such images are
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1
particularly useful in the assessment of brain function.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Hamamatsu PET Scanner Model SHR-22000 is a medical device, and it has similar indications for use as the legally marketed predicate device. The two devices have the same intended use.
The Hamamatsu PET Scanner Model SHR-22000 has the same technological characteristics as the predicate devices.
- This premarket notification describes most of the characteristics of the Hamamatsu PET Scanner Model SHR-22000 in sufficient detail to assure substantial equivalence. For a few characteristics, performance data is provided to assure equivalence.
TECHNOLOGICAL CHARACTERISTICS E.
The Hamamatsu PET Scanner Model SHR-22000 has the "same technological characteristics" as the predicate devices. Both employ coincidence detection from thousands of scintillator segments to reconstruct cross-sectional medical images using standard image reconstruction algorithms. The image processing algorithms in the workstation manipulate and display medical images on the workstation monitor.
F. TESTING
4
The Hamamatsu PET Scanner Model SHR-22000 was tested for compliance with the Japanese Industry Standard on electrical safety. Imaging performance tests were carried out to assure equivalence of image characteristics with the predicate device.
G. CONCLUSIONS
The 510(k) decision algorithm brings us to a determination of Substantial Equivalence, as defined in the Federal Food, Drug, and Cosmetic Act.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 17 1998
Hamamatsu Photonics, K.K. T. Whit Athey, Ph.D. c/o C.L. McIntosh & Associates 12300 Twinbrook Parkway Suite 625 Rockville. Maryland 20852
Re:
K982171 Hamamatsu PET Imaging System Model SHR-22000 Dated: June 18, 1998 Received: June 19, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your ........ responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmam.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Hamamatsu PET Scanner Model SHR-22000 Device Name:
Indications For Use:
ﺎﺕ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ
The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution of physiological tracer molecules labeled with positron-emitting isotopes. Such images are particularly useful in the assessment of brain function.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) . . . . . .
Concurrence of CDRH, Office of Device Evaluation (ODE) ----------
David W. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
000034