The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. It is an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using the MDPC-8127. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Device Story
Medical, color-calibrated 27-inch IPS LCD display; used by pathologists in clinical settings to review digital histopathology images. Inputs digital signals from IVD-labeled whole-slide imaging scanners via DisplayPort; processes images for high-resolution (8MP) visualization. Features built-in PPU (Color Per Pixel Uniformity) technology and I-Guard front sensor for constant accuracy. Output viewed by pathologist to aid primary diagnosis. Benefits include high-fidelity color and grayscale reproduction, ensuring consistent image quality for diagnostic interpretation.
Clinical Evidence
Bench testing only. Performance verified against FDA TPA guidance, including spatial resolution, pixel defects, artifacts, temporal response, luminance/chromaticity stability, and color gamut. Testing demonstrated MDPC-8127 meets or exceeds predicate performance. Compliance with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 62304 (software lifecycle) confirmed. System integration testing performed with validated WSI scanners and viewing software.
Technological Characteristics
27-inch IPS LCD with LED backlighting; 8MP resolution (3840x2160); 16:9 aspect ratio. Calibrated to sRGB and DICOM GSDF. Features: PPU (Color Per Pixel Uniformity), I-Guard front sensor, ambient light sensor. Connectivity: 2x DisplayPort 1.2, USB 2.0. Power: 100-240 Vac. Anti-glare coating. Standards: IEC 60601-1, IEC 62304, ISO 15223-1, ISO 14971.
Indications for Use
Indicated for use by pathologists to review and interpret digital images of FFPE histopathology slides for primary diagnosis. Not for use with frozen section, 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.
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
INSTRUMENT ONLY
## I Background Information:
A 510(k) Number
K203364
B Applicant
Barco NV
C Proprietary and Established Names
MDPC-8127
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PZZ | Class II | 21 CFR 864.3700 - Whole Slide Imaging System | PA - Pathology |
## II Submission/Device Overview:
A Purpose for Submission:
New digital pathology display
B Type of Test:
Digital Pathology Display
## 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:
The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. It is an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using the MDPC-8127. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
## IV Device/System Characteristics:
### A Device Description:
The Barco MDPC-8127 is a medical, color-calibrated display, specifically intended for review and interpretation of digital images of surgical pathology slides from IVD-labeled whole-slide imaging scanners and digital pathology image viewing software. The MDPC-8127 consists of a high-resolution 27-inch color LCD-panel and can be calibrated to the sRGB color gamut or other broader color spaces. The display uses built-in techniques to ensure constant accuracy over time. The display characteristics and specifications are provided in the Table below.
| Display Characteristics | |
| --- | --- |
| Screen technology | IPS LCD with LED backlighting |
| Active screen size (diagonal) | 684 mm (27") |
| Active screen size (H x V) | 569 x 335 mm (22.4 x 13.2") |
| Aspect ratio (H:V) | 16:9 |
| Resolution | 8MP (3840 x 2160 pixels @ 120 Hz) |
| Pixel pitch | 0.155 mm |
| Color imaging | Yes |
| Gray imaging | Yes |
| Color depth | 30 bit (1.07 billion possible colors) |
| Viewing angle (H, V) | 178° |
| Screen surface treatment | Anti-Glare coating |
| Uniformity Technology | PPU |
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| Display Characteristics | |
| --- | --- |
| Color calibration | sRGB, DICOM GSDF, |
| Color gamut NTSC | 115% (typical) |
| Color gamut sRGB | 132% (typical), 137.1% (measured) |
| Color gamut DCI-P3 | 105% (typical) |
| Ambient light presets | Yes, reading room selection |
| Ambient light sensor | Yes |
| Front sensor | Yes, I-Guard |
| Maximum luminance (panel typical) | 850 cd/m² |
| Calibrated luminance | 450 cd/m² |
| Contrast ratio (panel typical) | 1000:1 |
| sRGB Delta E2000 (typical) | < 1 (average)
< 3 (maximum) |
| Response time [(Tr + Tf)/2)] (typical) | 8 ms (typical), 5.01 ms (measured) |
| Housing color | Black / White |
| Video input signals | 2x DisplayPort 1.2 |
| USB ports | 1x USB 2.0 upstream (endpoint) 2x USB 2.0 downstream |
| Power rating | 100-240 Vac, 50/60 Hz, 3.6-1.6 A |
| Power consumption | 75 W (nominal) @ calibrated luminance of 450 cd/m²
< 0.5 W (hibernate)
< 0.5 W (standby) |
B Instrument Description Information:
1. Instrument Name:
MDPC-8127
2. Specimen Identification:
The FFPE tissue specimen is identified on the scanned images by patient-specific barcodes and/or patient identifying information present on the glass slides.
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3. Specimen Sampling and Handling:
Specimen sampling, which includes FFPE tissues, is performed by clinicians. Biopsy specimens are processed and FFPE slides are scanned by trained healthcare professionals to generate a digital image.
4. Calibration:
Calibrated color spaces: DICOM GSDF and sRGB
5. Quality Control:
Image quality is checked by the user for acceptability. In addition, quality checks for the display are initiated by the QAWeb quality assurance software and performed as a background activity.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Philips IntelliSite Pathology Solution
B Predicate 510(k) Number(s):
K192259
C Comparison with Predicate:
| | Device
K203364 | Predicate
K192259 |
| --- | --- | --- |
| Device Trade Name | Barco MDPC-8127 | Philips Intellisite Pathology Solution
MMPC-4227F1 (PP27QHD) |
| Device Characteristics - Similarities | | |
| Screen Technology | In-Plane Switching (IPS) Liquid Crystal Display (LCD) | Same |
| Display Calibration | Standard Red Green Blue (sRGB), Digital Imaging and Communication in Medicine (DICOM) | Same |
| Aspect ratio (H:V) | 16:9 | Same |
| Device Characteristics - Differences | | |
| Resolution | 8MP (3840 x 2160 pixels) | 3.6MP (2560 x1440 pixels) |
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| Uniformity Technology | Color Per Pixel Uniformity (PPU) | None |
| --- | --- | --- |
VI Standards/Guidance Documents Referenced:
1. FDA Guidance document: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices. Guidance for Industry and Food and Drug Administration Staff. April 20, 2016 (TPA Guidance).
2. ANSI/AAMI ES60601- 1:2005/(R)2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
3. IEC 62304 Edition 1.1 2015-06 Medical Device Software - Software Life Cycle Processes
4. ISO 15223-1 Third Edition 2016- 11-01 Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements
5. ISO 14971 Second edition 2007-03-01(5-40) Medical devices - application of risk management to medical devices.
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 for Barco MDPC-8127 display was performed according to the TPA guidance (section IV(A)(11)(b). Bench testing included assessment of the following performance characteristics:
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| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | MDPC-8127 | Predicate device |
| User controls | Out-of-the-box settings | Luminance target, maximum: 450 cd/m²
Display function: sRGB
White point: 6500K
Color space: sRGB
10 minutes of warm-up time | Luminance target, maximum: 350 cd/m²
Display function: sRGB
White point: 6500K
Color space: sRGB
10 minutes of warm-up time |
| Spatial resolution | Roehrig, Hans, et al. "In-field evaluation of the modulation transfer function of electronic display devices." *Medical Imaging 2004: Visualization, Image-Guided Procedures, and Display*. Vol. 5367. International Society for Optics and Photonics, 2004 | Both horizontal and vertical MTFs are greater than 85% at Nyquist frequency | Both horizontal and vertical MTFs are greater than 75% at Nyquist frequency |
| Pixel defects | 7.6 Defective Pixels, IDMS v1.03b | Total number of bright and dark pixels <= 5 with a minimum distance greater than 15 mm. | Total number of bright and dark pixels <= 3 within a circle of 10 mm. diameter |
| Artifacts | Image retention after 1 hour | < 0.65% | < 0.65% |
| Temporal response | 10.2.3 Gray-to-Gray Response Time, IDMS v1.03b | The response time ranges from 3.1 ms to 6.2 ms with an average of 5.01 ms. | The response time is maximum 15 ms and typical 8 ms. |
| Maximum and minimum luminance | 5 Fundamental Measurements, IDMS v1.03b | The maximum and minimum achievable luminance values are 678.6 and 0.633 cd/m², respectively.
The calibrated luminance target is 450 cd/m².
The contrast ratio is greater than 1000:1. | The maximum and minimum achievable luminance values are 550 and 0.3 cd/m², respectively.
The calibrated luminance target is 350 cd/m².
The contrast ratio is 1000:1. |
| Grayscale | Contrast response deviation, AAPM TG-18 | Maximum error calculated = 1.4% | Maximum error calculated = 2.1% |
| Luminance uniformity and Mura test | 8 Uniformity Measurements, IDMS v1.03b | <10% non-uniformity on 80% video level | 21% non-uniformity on 80% video level |
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| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | MDPC-8127 | Predicate device |
| Stability of luminance and chromaticity response | Luminance and chromaticity characteristics of the display measured with temperature and time | Deviation from target luminance (450 cd/m²): ±0.44%
Variations for luminance and chromaticity: < 5% deviation | Deviation from target luminance (350 cd/m²): ±0.2%
Variations for luminance and chromaticity: < 2% deviation |
| Bidirectional reflection distribution function | 11. Reflection Measurements, IDMS v1.03b | Specular reflection coefficient: 1.90%
Diffuse reflection coefficient: 2.87% | Specular reflection coefficient: 1.69%
Diffuse reflection coefficient: 2.21% |
| Gray tracking | 6.15 Gray-scale Color Changes, IDMS v1.03b | +/- 0.01 Δu’v’
White point at D65: +/- 0.01 Δu’v’ | +/- 0.002 Δu’v’
White point at D65: +/- 0.002 Δu’v’ |
| Color scale | 6. Gray- and Color-Scale Measurement, IDMS v1.03b | Average color error < 1 ΔE00
Maximum color error < 3 ΔE00 | Average color error < 2 ΔE00
Maximum color error < 5 ΔE00 |
| Color gamut volume | 5.18.1 Relative Gamut Area, IDMS v1.03b | 2D color gamut wrt sRGB: 137.1%
2D color gamut overlapped with sRGB: 99.6% | 2D color gamut wrt sRGB: 99.4%
2D color gamut overlapped with sRGB: 98.4% |
VIII Proposed Labeling:
The labeling is sufficient, and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable, and the special controls for this device type, as applicable.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K203364 - Page 7 of 7
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
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.
