(88 days)
Sopha Medical Sophy NXT, GE Medical Systems Genie System
Not Found
No
The summary describes standard image processing, archiving, and display functionalities typical of nuclear imaging software, with no mention of AI or ML terms or capabilities.
No
The device is described as acquiring, processing, displaying, and maintaining nuclear imaging studies, which are diagnostic functions, not therapeutic.
Yes
Explanation: The device is intended to "acquire, process, display and maintain nuclear imaging studies." The purpose of these studies is to obtain information about the body's function, which is then interpreted by a healthcare professional to diagnose or monitor medical conditions. This aligns with the definition of a diagnostic device.
Yes
The device description explicitly states that the MAPS 10000 is a "software program" designed to acquire, process, display, and manage nuclear imaging studies. While it interacts with existing hardware (gamma cameras and computer systems), the device itself is described solely as software.
Based on the provided information, the MAPS 10000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring, processing, displaying, and maintaining nuclear imaging studies obtained using compatible gamma camera systems. This is related to in vivo imaging (imaging within a living organism), not in vitro testing (testing outside of a living organism, typically on biological samples).
- Device Description: The description reinforces its role in handling nuclear images from gamma cameras, which are used for in vivo imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the MAPS 10000 is a medical device used for nuclear imaging, which is a form of in vivo diagnostic imaging.
N/A
Intended Use / Indications for Use
The MAPS 10000 is intended to acquire, process, display and maintain nuclear imaging studies obtained using compatible gamma camera systems.
The MAPS 10000 is a nuclear medicine software package intended to acquire, process, display and maintain nuclear imaging studies obtained using compatible gamma camera systems.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
The MAPS 10000 is designed to acquire nuclear images as well as provide image display and processing, database utilities, and archiving utilities of nuclear imaging studies obtained using compatible existing acquisition software (subsystem) and gamma cameras. It is designed to be compatible with networked gamma camera and analogue camera systems using a windows-based operating system.
MAPS 10000 includes a software program used to archive new nuclear imaging studies on a local disc drive or networked disc drive, to perform file management tasks on existing patient studies and data files (select, protect, copy, move, delete, and print); to import foreign patient studies and data; to display and process studies and data files; and to run pre-set and user-defined image protocols.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear imaging studies, gamma camera systems.
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Images were acquired, processed, and displayed using MAPS 10000.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Sopha Medical Sophy NXT, GE Medical Systems Genie System
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.
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MAPS 10000 Web Link Medical 510(k) Premarket Notification
Appendix IX, 510(k) Summary of Safety and Effectiveness Data Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I. General Information
| A. | Submitted By: | Web Link Medical
7720 Crosby Drive
Lone Tree, Colorado 80124-8966
Tel: (303) 790-8956
Fax: (303) 790-8958 |
|----|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Mr. Chris Barlow at address above |
| B. | Device Trade Name: | MAPS 10000 |
| | Common Name: | Gamma Camera Systems |
| | Classification Name: | Emission Computed Tomography System |
| C. | Predicate Device: | Sopha Medical Sophy NXT
GE Medical Systems Genie System |
- D. Device Description:
The MAPS 10000 is designed to acquire nuclear images as well as provide image display and processing, database utilities, and archiving utilities of nuclear imaging studies obtained using compatible existing acquisition software (subsystem) and gamma cameras. It is designed to be compatible with networked gamma camera and analogue camera systems using a windows-based operating system.
MAPS 10000 includes a software program used to archive new nuclear imaging studies on a local disc drive or networked disc drive, to perform file management tasks on existing patient studies and data files (select, protect, copy, move, delete, and print); to import foreign patient studies and data; to display and process studies and data files; and to run pre-set and user-defined image protocols.
- E. Indications for Use:
The MAPS 10000 is intended to acquire, process, display and maintain nuclear imaging studies obtained using compatible gamma camera systems.
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Technological Comparison: F.
The MAPS 10000, Sopha Sophy NXT, and GE Medical Systems Genie System have similar indications for use and overall function and they perform similarly with respect to data acquisition, processing, display and archiving.
II. Testing
Images were acquired, processed, and displayed using MAPS 10000.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Chris Barlow Vice President, Engineering Web Link Medical 7720 Crosby Drive Lone Tree, Colorado 80124 Re:
K992560 MAPS 10,000 Gamma Camera System Dated: August 2, 1999 Received: August 2, 1999 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Barlow:
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 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 redassified 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 III (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 (QS) 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 531 through 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
OAPT Daniel G. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K992560
Device Name: MAPS 10000
Web Link Medical Sponsor Name:
Indications For Use:
The MAPS 10000 is a nuclear medicine software package intended to acquire, process, display and maintain nuclear imaging studies obtained using compatible gamma camera systems.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
(División Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992560
Prescription Use Over-The-Counter Use
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