K172135 · Shanghai United Imaging Healthcare Co., Ltd. · JAK · Mar 2, 2018 · Radiology
Device Facts
Record ID
K172135
Device Name
uCT Computed Tomography X-ray System
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
Product Code
JAK · Radiology
Decision Date
Mar 2, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1750
Device Class
Class 2
Indications for Use
uCT 760/780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and indicated for the whole body (including head, neck, cardiac and vascular).
Device Story
Multi-slice X-ray CT scanner; features rotating tube-detector system; operates on fan beam principle. Inputs: X-ray transmission data collected at multiple angles during rotation. Processing: Filter back-projection (FBP) algorithm for image reconstruction; includes KARL iterative denoising and MAC metal artifact correction. Outputs: DICOM-format cross-sectional images. Used in clinical settings by trained operators (radiologists/technicians). System components: Gantry, X-ray source, detectors, patient table, console, image processing computer. Benefits: High-resolution imaging for diagnostic assessment; iterative reconstruction and artifact correction improve image quality; high power/mA/kV settings support imaging of patients with varying BMIs. Healthcare providers use images for clinical decision-making.
Clinical Evidence
No clinical study included. Substantial equivalence supported by non-clinical bench testing, including dosimetry, image performance tests, artifact evaluation (MAC), iterative denoising (KARL), and AEC performance studies.
Technological Characteristics
Multi-slice CT; solid-state GOS detectors; 80kW (uCT 760) or 100kW (uCT 780) power; continuous rotation; 700mm aperture; DICOM output. Standards: ES 60601-1, IEC 60601-2-44, IEC 60601-1-2, NEMA XR 25/28/29. Biocompatibility: ISO 10993-5, ISO 10993-10. Software: Moderate level of concern.
Indications for Use
Indicated for whole-body (head, neck, cardiac, vascular) cross-sectional imaging via computer reconstruction of X-ray transmission data.
Regulatory Classification
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.
Predicate Devices
Philips Plus CT scanner (Brilliance 40, Brilliance 64) (K033326)
Submission Summary (Full Text)
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Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang Qm&ra VP No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, 201807 Cn
March 12, 2018
Re: K172135
Trade/Device Name: uCT 760, uCT 780 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: July 3, 2017 Received: July 14, 2017
Dear Shumei Wang:
This letter corrects our substantially equivalent letter of March 2, 2018.
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 of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) K172135
Device Name uCT 760, uCT 780
### Indications for Use (Describe)
uCT 760/780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and indicated for the whole body (including head, neck, cardiac and vascular).
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized symbol that resembles the letter "U" with a horizontal line through the top portion. The color scheme is a muted teal or gray-blue.
# SECTION 2
510(k) Summary
SECTION 2 - 1 of 12
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is formed by two vertical lines and a horizontal line in the middle, creating a shape that resembles a "U" with a crossbar. The color of the text and the "U" symbol appears to be a dark gray or blue-gray.
## 510 (k) SUMMARY
- Date of Preparation 1. January 19, 2018
#### 2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com
#### 3. Identification of Proposed Device
Trade Name: uCT 760, uCT 780 Common Name: Computed Tomography X-ray System Model(s): uCT 760. uCT 780
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
#### Identification of Predicate Device(s) 4.
Predicate Device
510(k) Number: K033326 Device Name: "Philips Plus" CT scanner Model(s): Brilliance 40, Brilliance 64
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, also in a bold font. The logo is simple and modern in design.
#### 5. Device Description:
The uCT 760/780 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format. which can be used by post-processing applications.
The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, Vital Signal Module and Software. The system software is a program used for patient management, data management, X-ray scan control, image reconstruction, and image archive.
A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a crosssectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays.
There are two features for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.
This proposed device includes two models: uCT 760, uCT 780.The differences between the two models are as follows:
| Spec.<br>Model | HV Power | Rotation speed | Minimum<br>slice thickness | Maximum slices<br>generated per rotation |
|----------------|----------|-------------------------------------|----------------------------|------------------------------------------|
| uCT 760 | 80kW | Up to 0.35 sec per<br>360° rotation | 0.625mm | 128 |
| uCT 780 | 100kW | Up to 0.3 sec per<br>360° rotation | 0.5mm | 160 |
#### 6. Indications for Use
uCT 760/780 is a computed tomography X-ray system intended to produce crosssectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).
- Comparison of Technological Characteristics with the Predicate Devices 7.
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized "U" shape, which is dark teal in color and has a white vertical line running through the center.
The uCT 760/780 Computed Tomography X-ray system has the same indications for use as the predicate device "Philips Plus" CT scanner. The fundamental scientific technology of the proposed device is same as the predicate device.
Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the predicate device.
| ITEM | Proposed Device<br>uCT 760, uCT 780 | Predicate Device<br>Brilliance 40, Brilliance 64 | Remark | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------|
| General | | | | |
| Product Code | JAK | JAK | Same | |
| Regulation No. | 21 CFR 892.1750 | 21 CFR 892.1750 | Same | |
| Class | II | II | Same | |
| Intended Use | The uCT Computed<br>Tomography X-ray System is a<br>computed tomography x-ray<br>system intended to produce<br>cross-sectional images of the<br>body by computer<br>reconstruction of x-ray<br>transmission data taken at<br>different angles and planes and<br>indicated for the whole body<br>(including head, neck, cardiac<br>and vascular). | The "Philips Plus" is a Whole<br>Body Computed Tomography<br>X-Ray System intended to<br>produce cross-sectional<br>images of the body by<br>computer reconstruction of x-<br>ray transmission data taken at<br>different angles and planes. | Same | |
| Specifications | | | | |
| Scan Regime | Continuous Rotation | Continuous Rotation | Same | |
| Scan Modes | Scout<br>Axial Scan<br>Helical Scan | Surview<br>Axial Scan<br>Helical Scan | Same | |
| Detector<br>Material | Solid-state GOS | Solid-state GOS | Same | |
| Z-plane<br>coverage | 40mm | 40mm | Same | |
| Size of detector<br>element in Z-<br>plane | 0.5mm | 0.625mm | Note<br>No.1 | |
| Number of<br>element per row | 936 | 672 | Note<br>No.2 | |
| Number of<br>detector row | 80 | 40 for Brilliance 40<br>64 for Brilliance 64 | Note<br>No.3 | |
| Maximum slices<br>generated per | 128 for uCT 760<br>160 for uCT 780 | 40 for Brilliance 40<br>64 for Brilliance 64 | Note<br>No.4 | |
| rotation (multi-slice capability) | | | | |
| Minimum slice thickness | 0.625mm for uCT 760<br>0.5mm for uCT 780 | 0.625mm | Same | |
| Maximum sampling rate | Up to 4800 views per 360° | Up to 4640 views per 360° | Note No.5 | |
| Tube anode storage capacity | 7.5MHU | 8.0MHU | Note No.6 | |
| Maximum cooling rate | 1386 kHU/min | 1608kHU/min | Note No.7 | |
| Focal spot size | 0.7x0.7mm<br>1.0x1.0mm | 0.5x1.0mm<br>1.0x1.0mm | Note No.8 | |
| Power | 80kW for uCT 760<br>100 kW for uCT 780 | 60 kW | Note No.9 | |
| mA Range | 6-667mA for uCT 760<br>6-833mA for uCT 780 | 30-500mA for Brilliance 40<br>20-500mA for Brilliance 64 | Note No.10 | |
| kV Settings | 70, 80, 100, 120, 140 | 80, 120, 140 | Note No.11 | |
| Aperture | 700mm | 700mm | Same | |
| Rotation speed | Up to 0.35 sec per 360° rotation for uCT 760<br>Up to 0.3 sec per 360° rotation for uCT 780 | Up to 0.42 sec per 360° rotation for Brilliance 40<br>Up to 0.4 sec per 360° rotation for Brilliance 64 | Note No.12 | |
| Temporal resolution | As low as 35ms | As low as 42ms | Note No.13 | |
| Gantry Tilt | ± 30°with 0.5 increment | ± 30°with 0.5 increment | Same | |
| Scannable range | 1700 mm | 1750mm | Note No.14 | |
| Horizontal motion range | 2180 mm | 1900mm | Note No.15 | |
| Table Horizontal Speed | Up to 200mm/sec | Up to 143mm/sec | Note No.16 | |
| Vertical motion range | 480 mm-950 mm from the floor | 578-1028mm | Note No.17 | |
| Vertical speed | Up to 40 mm/sec | Up to 50mm/sec | Note No.18 | |
| Table Horizontal Position accuracy | ±0.25mm | ±0.25mm | Same | |
| Table Maximum table load | 205kg | 204kg | Note No.19 | |
| Image Spatial Resolution | High mode:<br>20 lp/cm @ MTF 0% | High mode:<br>16.0lp/cm 0% | Note No.20 | |
| | | | | |
| | 16.5 lp/cm @ MTF10%<br>11.5 lp/cm @ MTF50% | 12.0 lp/cm @ MTF10%<br>6.0 lp/cm @ MTF50% | | |
| Image Noise | 3.0 HU at 120 kV, 5 mm slice thickness, CTDIvol 29.1mGy | 4.0 HU at 120 kV, 5 mm slice thickness, CTDIvol 27.3mGy | Note<br>No.21 | |
| CT Number<br>Display Range | -1024 ~+8191 HU | -1024 ~+3072 HU | Note<br>No.22 | |
| Scan Field of<br>View | Up to 500 mm<br>600mm with extend FOV | Up to 500 mm | Same | |
| Reconstruction<br>Field of View | 40mm-500mm<br>40mm-600mm with extend FOV | 50mm-500mm<br>25mm-250mm (Ultra High mode) | Note<br>No.23 | |
| Maximum<br>scannable length | 1700mm | 1750mm | Note<br>No.24 | |
| Image Matrix | Up to 1024 x 1024 | Up to 1024 x 1024 | Same | |
| Reconstructed<br>slice thickness | uCT 760:<br>0.625mm,1.25mm,2.5mm,5mm,10mm (axial)<br>0.625-10mm(helical)<br>uCT 780:<br>0.5mm,0.625mm,1.25mm,2.5mm,5mm,10mm (axial)<br>0.5-10mm(helical) | Spiral mode:0.67 -7.5mm<br>Axial mode:0.5-12mm | Note<br>No.25 | |
| | Pitch | 0.1~2.0 | 0.13~1.5 | Note<br>No.26 |
| | Maximum<br>continuous<br>exposure time | Up to 100seconds | Up to 100seconds | Same |
| | Slip ring | 6.25 Gbps transfer rate | Up to 5.3 Gbps transfer rate | Note<br>No.27 |
| | RAM | 24GB for console PC<br>32GB for Recon PC | 2.0GB<br>4.0GB (optional ) | Note<br>No.28 |
| | Display | 24inch, 1200 x 1920 | 19inch, 1024 x 1280 | Note<br>No.29 |
| | Safety | | | |
| Electrical Safety | Comply with ES60601-1 | Comply with IEC60601-1 | Same | |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same | |
| Biocompatibility | Patient Contact Materials were<br>tested and demonstrated no<br>cytotoxicity (ISO 10993-5), no<br>evidence for irritation and<br>sensitization (ISO 10993-10). | Comply with ISO10993-5,<br>ISO10993-10 | Same | |
| | Clinical | Sample clinical image for both proposed and predicate devices are<br>provided in Section 15 Clinical Evaluation. Electronic file for each image<br>are provide in MISC Folder. | | |
Table 1 Comparison of Technological Characteristics
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Image /page/7/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED IMAGING" is in bold, dark blue letters. To the right of the text is a stylized, dark blue icon that resembles the letter "U" with a horizontal line through the top portion.
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized, geometric symbol that resembles a capital "U" with a horizontal line across the top, creating a shape that also looks like a stylized "H". The color of both the text and the symbol is a dark teal or gray.
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Image /page/9/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is formed by two vertical lines and a horizontal line connecting them at the top. The logo is simple and modern, and the use of bold fonts and geometric shapes gives it a strong and recognizable presence.
| Note ID | Justification | |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 1 | Provides the smaller minimum detector element size that induces higher<br>z-plane spatial resolution for CT imaging, which does not affect safety<br>and effectiveness. | |
| Note 2 | Provides the larger detector element number per row that induces more<br>data sampling and higher spatial resolution per row for CT imaging,<br>which does not affect safety and effectiveness. | |
| Note 3 | The move to 80 slices is the addition of physical detectors increasing the<br>total number of slices to 80, which does not affect safety and<br>effectiveness. | |
| Note 4 | With a reconstruction process and reduction in (“windmill”) artifacts, 128<br>slices or 160 slices can be achieved from the 80 detectors. Neither of<br>these changes affects safety and effectiveness. | |
| Note 5 | Provides the larger maximum sampling rate based on the full view (360°)<br>that induces more data sampling and higher spatial resolution for CT<br>imaging, which does not affect safety and effectiveness. | |
| Note 6 | Tube anode storage capacity is a kind of measurement about the<br>maximum throughput of CT scanner. When an independent scan is<br>implemented, the tube is heated and if the time interval between two<br>independent scans is long enough, the heat can be dissipated timely but<br>for short scan time interval, the heat which has not been dissipated timely<br>should be stored within tube device and thus for the continuous scans (for<br>short scan time intervals), higher storage capacity means that more<br>continuous scan numbers can be supported. However, tube anode storage<br>capacity has no effect on each independent scan. | |
| Note 7 | Similarly with Note 7, maximum cooling rate is a kind of measurement<br>about the maximum throughput of CT scanner. For the continuous scans,<br>higher maximum cooling rate means that the tube heat can be dissipated<br>faster and thus shorter scan time interval and more continuous scan<br>numbers can be supported. However, it has no effect on each independent<br>scan. | |
| Note 8 | Focus spot size has effect on image spatial resolution and smaller size is<br>helpful for resolution improvement. However, the image spatial resolution<br>between the two kinds of devices is equivalent substantially. | |
| Note 9 | Provide the larger power output that induces higher ability of x-ray<br>penetration when scanning the object with high BMI with lower<br>possibility of photon starvation, and the safety has been evaluated by the<br>related testing and verification. | |
| Note 10 | Provide the larger mA output that induces higher ability of x-ray<br>penetration when scanning the object with high BMI with lower<br>possibility of photon starvation, and the safety has been evaluated by the<br>related testing and verification. | |
| | of photon starvation, and the safety has been evaluated by the related<br>testing and verification. | |
| Note 11 | Provide small kV output such as 70kV that induces lower ability of x-ray<br>penetration when scanning the object with low BMI with lower possibility<br>of photon starvation, and the safety has been evaluated by the related<br>testing and verification.<br>Provide 100KV output that induces more feasible ability of x-ray penetration when scanning the object with various BMIs, and the safety<br>has been evaluated by the related testing and verification. | |
| Note 12 | Provides the shorter minimum scan time that induces better temporal<br>resolution in advanced clinical applications, including cardiac imaging,<br>which does not affect safety and effectiveness. | |
| Note 13 | Provides the shorter temporal resolution that reduces motion artifacts of<br>cardiac imaging and increase the image quality, which does not affect<br>safety and effectiveness. | |
| Note 14 | Scannable range between the two kinds of devices is equivalent<br>substantially because both of them can cover all kinds of the height range<br>of current humans and they offer helical scanner mode to scan the whole<br>body from various human instead. | |
| Note 15 | Provide the larger horizontal motion range that induces larger scan range,<br>which does not affect safety and effectiveness. | |
| Note 16 | Provide the larger table horizontal speed that induces shorter scan time<br>with the other given scan conditions such as scan range and parameters,<br>which does not affect safety and effectiveness. | |
| Note 17 | Vertical motion range is decided by device gantry and couch design<br>which does not affect safety and effectiveness. | |
| Note 18 | Vertical speed between the two kinds of devices is equivalent<br>substantially and 10mm/sec difference does not affect safety and<br>effectiveness. | |
| Note 19 | The maximum table load between the two kinds of devices is equivalent<br>substantially because both of them can cover all kinds of the load range of<br>current humans. | |
| Note 20 | Providing the higher image spatial resolution is helpful to distinguish the<br>smaller structure, which does not affect safety and effectiveness. | |
| Note 21 | With 120 kV and 5mm slice thickness, the image noise for typical head is<br>3HU on CTDIvol 29.1mGy, which is better than 4HU on CTDIvol<br>27.3mGy. But the image noise level is equivalent substantially<br>considering the proposed device has measured its noise based on the<br>larger CTDIvol than the Predicate Device. | |
| Note 22 | Provides the large HU range that induces more choice for various clinical<br>scan situation and show more information in clinical images, which does<br>not affect safety and effectiveness. | |
| Note 23 | Reconstruction Field of View between the two kinds of devices is<br>equivalent substantially and the difference from lower limits does not<br>affect safety and effectiveness. | |
| | | |
| Note 24 | Maximum scannable length between the two kinds of devices is equivalent substantially because both of them can cover all kinds of the load range of current humans. | |
| | Note 25 | Provides the more slice thickness that induce more choice for various clinical scan situations and thinner slice thickness should bring higher spatial resolution in z-plane, which does not affect safety and effectiveness. |
| Note 26 | | Provides the large pitch range that induces more choice for various clinical scan situations, which does not affect safety and effectiveness. |
| | | Note 27 |
| Note 28 | | |
| | Note 29 | |
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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.
# SECTION 2 - 8 of 12
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Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray. The logo is simple and mo…
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.