INFINITT DPS

K243449 · Infinitt Healthcare Co., Ltd. · QKQ · Dec 9, 2025 · Pathology

Device Facts

• Record ID: K243449
• Device Name: INFINITT DPS
• Applicant: Infinitt Healthcare Co., Ltd.
• Product Code: QKQ · Pathology
• Decision Date: Dec 9, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.3700
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

INFINITT DPS is a software device intended for viewing and management of whole slide digital images derived from scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It serves as an aid for pathologists to review and interpret these digital images for the purpose of pathology primary diagnosis. INFINITT DPS is intended for use with Hamamatsu NanoZoomer S360MD scanner and Barco MDPC-8127 display. It is the responsibility of the pathologist to implement appropriate procedures and safeguards that assure the integrity and accuracy of image interpretation when utilizing the INFINITT DPS. The system is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

Device Story

Web-based software for viewing/managing whole slide images (WSIs) in pathology; replaces physical microscopes. Inputs: NDPI files from Hamamatsu NanoZoomer S360MD scanner. Processing: Acquisition module converts NDPI to DICOM; stores on server; integrates with LIS/EMR. Output: WebViewer interface for pathologists to zoom, pan, rotate, measure, and annotate images. Used in hospital pathology departments. Pathologists use output for primary diagnosis; aids clinical decision-making by enabling digital review. Benefits: improved workflow efficiency and convenience.

Clinical Evidence

No clinical data. Bench testing only. Pixel-wise comparison of 270 image-pairs across 30 FFPE slides (normal/tumor) at 10x, 20x, 40x magnification demonstrated identical image reproduction (95th percentile ΔE00 < 3). Measurement accuracy testing (length/area) confirmed performance within ±2% or ±5 μm for length and ±5% for area. Turnaround time testing confirmed loading ≤ 5s and navigation ≤ 1s. Summative human factors testing validated safe/effective use by pathologists.

Technological Characteristics

Web-based software; DICOM-compliant; supports Chrome, Edge, Firefox. Server requirements: Windows Server 2016+, Oracle 19c, 1Gbps network. Image manipulation: zoom, pan, rotate, measurement tools. No AI/ML models. Cybersecurity: SAST, dynamic analysis, penetration testing (MITRE ATT&CK).

Indications for Use

Indicated for pathologists to view and manage whole slide digital images of FFPE surgical pathology slides for primary diagnosis. Not for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

Regulatory Classification

Identification

The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.

Special Controls

A whole slide imaging system must comply with the following special controls: (1) Premarket notification submissions must include the following information: (i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system. (ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate: (A) Slide feeder; (B) Light source; (C) Imaging optics: (D)Mechanical scanner movement; (E) Digital imaging sensor; (F) Image processing software; (G)Image composition techniques; (H)Image file formats; (I) Image review manipulation software; (J) Computer environment; (K)Display system. (iii)Detailed bench testing and results at the system level, including for the following, as appropriate: (A)Color reproducibility; (B) Spatial resolution; (C) Focusing test; (D) Whole slide tissue coverage; (E) Stitching error: (F) Turnaround time. (iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate: (A)Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (e.g., main sign-out diagnosis). (D) A detailed human factors engineering process must be used to evaluate the whole slide imaging system user interface(s). (2) Labeling compliant with 21 CFR 809.10(b) must include the following: The intended use statement must include the information described in paragraph (i) (1)(i) of this section, as applicable, and a statement that reads, "It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device." (ii) A description of the technical studies and the summary of results, including those that relate to paragraph (1)(ii) and (1)(iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (1)(iv) of this section, as appropriate. (iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information: (i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system. (ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate: (A) Slide feeder; (B) Light source; (C) Imaging optics; (D) Mechanical scanner movement; (E) Digital imaging sensor; (F) Image processing software; (G) Image composition techniques; (H) Image file formats; (I) Image review manipulation software; (J) Computer environment; and (K) Display system. (iii) Detailed bench testing and results at the system level, including for the following, as appropriate: (A) Color reproducibility; (B) Spatial resolution; (C) Focusing test; (D) Whole slide tissue coverage; (E) Stitching error; and (F) Turnaround time. (iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate: (A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference ( *e.g.,* main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s). (2) Labeling compliant with 21 CFR 809.10(b) must include the following: (i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.” (ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate. (iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.

Predicate Devices

• NanoZoomer S360MD Slide scanner system (K233027)

Submission Summary (Full Text)

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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K243449

B Applicant

INFINITT Healthcare Co., Ltd.

C Proprietary and Established Names

INFINITT DPS

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QKQ | Class II | 21 CFR 864.3700 - Whole Slide Imaging System | PA - Pathology |

## II Submission/Device Overview:

A Purpose for Submission:

New device

B Type of Test:

Software only device

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) for Use:

INFINITT DPS is a software device intended for viewing and management of whole slide digital images derived from scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It serves as an aid for pathologists to review and interpret these digital images for the purpose of pathology primary diagnosis.

INFINITT DPS is intended for use with Hamamatsu NanoZoomer S360MD scanner and Barco MDPC-8127 display.

It is the responsibility of the pathologist to implement appropriate procedures and safeguards that assure the integrity and accuracy of image interpretation when utilizing the INFINITT DPS. The system is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

IV Device/System Characteristics:

A Device Description:

INFINITT DPS, version 1.1, is a web-based software device that enables qualified pathologists to review digital whole slide images (WSIs) of formalin-fixed, paraffin-embedded (FFPE) tissue specimens for pathology primary diagnosis. The device operates through a supported web browser without installing any application locally.

The operation and workflow of INFINITT DPS are described below:

- Data Input: The device accepts WSI files in the NDPI file format generated by a Hamamatsu NanoZoomer S360MD Slide scanner. The WSI files are internally converted into the Digital Imaging and Communications in Medicine (DICOM) file format using the built-in INFINITT DPS Acquisition module.
- Data Management and Storage: The converted images are stored on the INFINITT DPS server. The user is highly recommended to create a backup of the original NDPI files. The device can be integrated with an external LIS (Laboratory Information System) /EMR (Electronic Medical Record) system to automate case registration and retrieval.
- Image Access and Navigation: Users can log into the device using the INFINITT DPS WebViewer running on a supported web browser (i.e., Chrome, Edge, or Firefox). The stored WSIs can be searched, selected, and opened directly within the INFINITT DPS WebViewer.
- Image Review and Interpretation: INFINITT DPS WebViewer provides the following interactive features:

- Zoom, pan, and rotate for image navigation
- Measurement tools for length and area

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The interoperable components of INFINITT DPS and other system specifications are provided in tables 1 - 3 below.

Table 1. Interoperable Components for Use with INFINITT DPS

| Components | Manufacturer | Model |
| --- | --- | --- |
| Scanner | Hamamatsu | NanoZoomer S360MD Slide scanner |
| Display | Barco | MDPC-8127 |

Table 2. Computer Environment / System for Use with INFINITT DPS

| Component | Requirement |
| --- | --- |
| Operating System | Windows 11 |
| Memory | 32GB RAM |
| Processor | Intel Core i7-11800H |
| Supported Browsers | Google Chrome version 90.0 and above Microsoft Edge version 90.0 and above Mozilla Firefox version 80.0 and above |

Table 3. Server System Requirements

| Component | Web Server | Database Server |
| --- | --- | --- |
| CPU | 2.8GHz 12-core or higher | 2.2GHz 8-core or higher |
| Memory | 64GB or more | 16GB or more |
| Storage | 2TB or more | 4TB or more |
| Software Platforms | Microsoft IIS (Internet Information Services) 10 or higher | |
| Operating Systems | Microsoft Windows Server 2016 or higher | |
| Database | N/A | Oracle Database 19c or higher |
| Network | 1Gbps | 1Gbps |

# B Instrument Description Information:

1. Instrument Name: INFINITT DPS
2. Specimen Identification: Glass slides and scanned WSIs are identified based on the previously assigned specimen identifiers such as patient identifiers, barcodes, etc. Digital images of Hematoxylin and Eosin (H&amp;E) stained surgical pathology glass slides prepared from FFPE tissue are obtained using the Hamamatsu NanoZoomer S360MD Slide scanner. INFINITT DPS receives digital image files generated by the Hamamatsu NanoZoomer S360MD Slide scanner. Specimen identification within the system is managed using metadata and digital identifiers associated with each scanned FFPE tissue slide. These identifiers are displayed in the INFINITT DPS interface to allow pathologists to access, review, and organize digital slides. The system does

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not modify or assign specimen identifiers and relies on scanner-generated and system-ingested data for digital slide tracking.

# 3. Specimen Sampling and Handling:

Specimen sampling and handling are performed upstream and independent of the use of the subject device. Specimen sampling includes surgical pathology biopsy or resection specimens which are processed using standard histology techniques. The FFPE tissue sections are stained using the H&amp;E staining procedure. INFINITT DPS does not perform or manage physical specimen sampling or handling.

# 4. Calibration:

INFINITT DPS relies on properly calibrated image input from the scanner and does not modify or perform any calibration functions within the software.

# 5. Quality Control:

Prior to using a WSI for diagnosis, it is the responsibility of the laboratory staff, while scanning glass slides and uploading WSIs, and the pathologist, while reviewing the WSIs, to ensure that all scanned slide images have been imported for every case and the images are of acceptable quality for diagnostic purposes per their laboratory standards. Additional details of the quality control procedures are provided in the device's user manual.

# V Substantial Equivalence Information:

# A Predicate Device Name(s):

NanoZoomer S360MD Slide scanner system

# B Predicate 510(k) Number(s):

K233027

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K243449 | K233027 |
| --- | --- | --- |
| Device Trade Name | INFINITT DPS | NanoZoomer S360MD Slide scanner system |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | INFINITT DPS is a software device intended for viewing and management of whole slide digital images derived from scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It serves as an aid for pathologists to review and interpret these digital images for the purpose of pathology primary diagnosis. | The NanoZoomer S360MD Slide scanner system (“NanoZoomer System”) is an automated digital slide creation, viewing, and management system. The NanoZoomer System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (“FFPE”) tissue. The NanoZoomer System is not intended for use with frozen |

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| | INFINITT DPS is intended for use with Hamamatsu NanoZoomer S360MD scanner and Barco MDPC-8127 display.

It is the responsibility of the pathologist to implement appropriate procedures and safeguards that assure the integrity and accuracy of image interpretation when utilizing the INFINITT DPS. The system is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. | section, cytology, or non- FFPE hematopathology specimens.

The NanoZoomer System comprises the NanoZoomer S360MD Slide scanner, the NZViewMD Software and a compatible display that has been 510(k) cleared for use with the NanoZoomer system or a 510(k)-cleared display that has been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying additional compatible displays. The NanoZoomer System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using NanoZoomer System. |
| --- | --- | --- |
| Specimen Type | Surgical pathology slides prepared from FFPE tissue | Same |
| Diagnostic Image File Format | Hamamatsu NDPI File | Same |
| Image Storage | User-supplied network attached storage Same | Same |
| **General Device Characteristic Differences** | | |
| Image manipulation functions | Panning, zooming, annotations, and measurements (distance & area) | Panning, zooming, annotations, and measurements (distance & area) |
| Type of Software Application | Internet browser-based application | PC-based installed application |
| End User’s Interface | INFINITT DPS | NZViewMD |

VI Standards/Guidance Documents Referenced:

1. FDA Guidance “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices”. April 20, 2016.
2. FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices”. February 3, 2016.
3. FDA Guidance “Content of Premarket Submissions for Device Software Functions”. June 14, 2023.
4. FDA Guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. September 27, 2023.

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5. ISO 14971 Third Edition 2019-12, 5-125, Medical devices – Applications of risk management to medical devices.
6. IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, 13-79. Medical device software – Software life cycle processes.
7. ICE 60812 Edition 3.0 2018-08, 5-120, Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)

## VII Performance Characteristics (if/when applicable):

### A Analytical Performance:
1. **Precision/Reproducibility:**
Not applicable
2. **Linearity:**
Not applicable
3. **Analytical Specificity/Interference:**
Not applicable
4. **Accuracy (Instrument):**
Not applicable
5. **Carry-Over:**
Not applicable

### B Other Supportive Instrument Performance Characteristics Data:

Technical performance testing was conducted with the subject device, INFINITT DPS as specified below.

#### 1. Bench Testing - Pixelwise comparison test

Pixel-wise comparison testing to demonstrate identical image reproduction was conducted to compare WSIs reproduced by the subject device and the comparators as listed in Table 4 below. The subject device was compared to the predicate device’s image review manipulation software (IRMS, as defined in FDA guidance document, “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices” dated April 20, 2016) using the quantitative pixel-wise comparison method. The basis for the comparison was the CIEDE2000 color difference equation, $\Delta E_{00}$. The devices were tested as operating with the intended components, including the scanner, specific file format, image management systems (subject device with the intended browsers and the comparator [predicate device IRMS]) and displays, as specified in the Table 4 below.

For each of the configurations in Table 4 below, the device was tested with multiple slides across multiple regions of interest (ROI) at multiple magnification levels. A total of 30 FFPE glass slides of normal and tumor tissues from various human anatomical organs were used in the testing. For each configuration, the glass slides were scanned on a corresponding

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intended scanner to obtain 30 WSIs. For each of the 30 WSIs, 3 ROIs from different locations were selected by qualified personnel to represent various features in the tissue samples. Each ROI was captured at 3 magnification levels (10x, 20x, 40x).

Screenshots were captured for the intended display while viewing with the subject device and predicate device IRMS. The screenshots were cropped and registered to be pixelwise comparable. The cropped image included most of the pixels in the image except for those in the viewer-specific user interface areas.

For each configuration, two sets of images were collected: comparator (predicate device IRMS) and the subject device (INFINITT DPS with the intended browser). Each image set included 270 images that covered all combinations of 30 slides, 3 ROIs and 3 magnification levels. The testing data, including the overview images of the 30 glass slides with annotations of the ROIs, registration/cropping information, and captured images, were provided in the FDA specific format.

The comparator (predicate device IRMS) image set was used as the reference to compare the subject device image set to determine whether all the 270 image-pairs were identical for each configuration and each intended display. Two images are considered identical if the 95th percentile of the pixelwise differences, computed using the International Commission on Illumination (CIE) color difference metric CIEDE2000 ( $\Delta E_{00}$ ), is less than $3\Delta E_{00}$ . Testing results showed that the pixelwise differences across all 270 image-pairs per configuration and per intended display were less than $3\Delta E_{00}$ . The maximum (max), minimum (min), and mean of the 95th percentile $\Delta E_{00}$ value were reported in Table 4. Testing results demonstrated that WSIs reproduced by INFINITT DPS are identical to images reproduced by the predicate devices.

Table 4: INFINITT DPS Pixelwise Comparison Testing Results

| Scanner | Subject Device /Browser | Comparator (Predicate device IRMS) | Display | Results |
| --- | --- | --- | --- | --- |
| NanoZoomer S360MD Slide scanner | INFINITT DPS /Chrome | NZViewMD | Barco MDPC-8127 | max (95th percentile ΔE00) = 0 |
| | | | | min (95th percentile ΔE00) = 0 |
| | | | | mean (95th percentile ΔE00) = 0 |
| | INFINITT DPS /Edge | NZViewMD | | max (95th percentile ΔE00) = 0 |
| | | | | min (95th percentile ΔE00) = 0 |
| | | | | mean (95th percentile ΔE00) = 0 |
| | INFINITT DPS /Firefox | NZViewMD | | max (95th percentile ΔE00) = 0 |
| | | | | min (95th percentile ΔE00) = 0 |
| | | | | mean (95th percentile ΔE00) = 0 |

# 2. Turnaround Time

Turnaround times (TAT) for image loading, panning and zooming were tested with INFINITT DPS when using all the supported browsers, as listed in table 5 below. H&amp;E-stained FFPE slide was scanned using the intended scanner to generate WSI. Below acceptance criteria was used:

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- Initial slide load time: ≤ 5 seconds
- Panning/zooming response time: ≤ 1 second

Test results for different scenarios met the test acceptance criteria and showed acceptable turnaround time for the intended use of the subject device, as shown in table 5 below.

Table 5: INFINITT DPS Turnaround Time Testing Results
| Subject Device / Browser | Loading (Mean) | Panning (Mean) | Zooming (Mean) |
| --- | --- | --- | --- |
| INFINITT DPS / Chrome | 2.7 seconds | 0.45 seconds | 0.48 seconds |
| INFINITT DPS / Edge | 2.9 seconds | 0.51 seconds | 0.49 seconds |
| INFINITT DPS / Firefox | 2.8 seconds | 0.48 seconds | 0.46 seconds |

## 3. Measurement – length and area

Measurement accuracy testing was performed to demonstrate that INFINITT DPS accurately represents length and area measurements. A total of 3 H&amp;E-stained, FFPE slides containing normal and tumor tissue from various organs were used. Measurements were taken at 20x and 40x magnifications with 2 different orientations across 7 annotation types: Arrow, Freehand Region, Freehand Line, Circle, Rectangle, Ruler, and Pin. Tests were performed using three browsers (Chrome, Edge, Firefox), and results were compared against the predicate viewer. Each measurement was repeated and analyzed to assess both accuracy and repeatability.

The acceptance criteria were
- Length: within ±2% or ±5 μm, whichever is greater
- Area: within ±5%

Test results show that all measurements performed using INFINITT DPS fell within the predefined tolerance ranges. The subject device performed accurate measurements across multiple magnification settings with respect to its intended use.

## 4. Human Factor (Usability) Testing

The usability test was conducted per FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices (2016)”. A summative human factors test, designed around critical user tasks and use scenarios using multiple representative users (pathologists), was conducted. All tasks associated with reviewing and reporting results for cases including confirmation that all slides belonging to specific cases are reviewed before reporting results were included in the study. The INFINITT DPS device has been found to be safe and effective for the intended users, uses and use environments.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

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IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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