Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
Device Facts
| Record ID | K152030 |
|---|---|
| Device Name | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) |
| Applicant | Qingdao Hisense Medical Equipment Co., Ltd. |
| Product Code | PGY · Radiology |
| Decision Date | Sep 16, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
Intended Use
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Device Story
The Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a medical-grade display system used by trained medical practitioners in clinical settings to view digital medical images. The device accepts digital video signals (DVI-D, Display Port) from medical imaging workstations and renders them on a high-resolution TFT color LCD screen. It features an integrated brightness stabilization circuit, a front sensor, and an ambient light sensor to ensure consistent image quality and calibration. The monitor supports both landscape and portrait orientations and includes an antiglare screen to minimize reflections. By providing stable, high-resolution visualization, the device assists clinicians in the review and analysis of diagnostic images, facilitating clinical decision-making. It does not perform automated diagnostic analysis but serves as a tool for visual interpretation.
Clinical Evidence
Bench testing only. The device was evaluated for performance, electrical/mechanical safety, and electromagnetic compatibility per IEC 60601-1 and IEC 60601-1-2 standards. No clinical data was required or provided.
Technological Characteristics
21.2"/21.3" TFT color LCD screen with antiglare coating. Native resolutions: 2048x1536 (HMD3C21) and 1600x1200 (HMD2C21). Connectivity: DVI-D, Display Port, USB. Features: brightness stabilization circuit, front sensor, ambient light sensor. Power: DC24V. Compliance: IEC 60601-1, IEC 60601-1-2, 21 CFR 1020.33.
Indications for Use
Indicated for trained medical practitioners to display and view digital images (excluding digital mammography) for review and analysis.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
- BARCO N.V., Coronis 3MP (MDCG-3221) (K131246)
- BARCO N.V., Nio 2MP (MDNC-2221) (K133663)
Related Devices
- K160347 — Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 · Qingdao Hisense Medical Equipment Co., Ltd. · Mar 3, 2016
- K222132 — Hisense LCD monitor HMD2G21S, HMD3G21S · Qingdao Hisense Medical Equipment Co., Ltd. · Nov 8, 2022
- K140103 — 3MP GRAYSCAKE LCD DISPLAY · Shenzhen Beacon Display Technology Co., Ltd. · Feb 14, 2014
- K172815 — 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) · Shenzhen Beacon Display Technology Co., Ltd. · Oct 27, 2017
- K140108 — 3MP COLOR LCD DISPLAY · Shenzhen Beacon Display Technology Co., Ltd. · Feb 14, 2014
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
Qingdao Hisense Medical Equipment Co., Ltd. % Mr. Liu Zhitang Regulatory Manager Software Outsourcing Center 3rd Floor North Wing No. 169 Songling Road, Laoshan Qing dao, Shan dong 266101 P.R. CHINA
Re: K152030
Trade/Device Name: Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 7, 2015 Received: July 22, 2015
Dear Mr. Zhitang:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ochs
Robert 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) K152030
Device Name
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
Indications for Use (Describe)
The 2MP/3MP LCD Monitor (HMD2C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <div style="display:inline-block;">☒</div> Residential Use (Rentals of 30+ Consecutive Days) |
|--------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block;">☐</div> Care/Elderly Services Use (Rentals of 30+ Consecutive Days) |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
[As required by 21 CFR 807.92]
### 1. Date Prepared [21 CFR807.92 (a) (1)]
Jul 8th, 2015
### 2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Qingdao Hisense Medical Equipment Co., Ltd. |
|------------------|-----------------------------------------------------------------------------------------------------------------|
| Address: | Software outsourcing center 3rd floor north wing, No.169<br>Songling Road, Laoshan Dist. 266101, Qingdao, China |
| Contact Name: | Liu Zhitang |
| Telephone No.: | +86 ( 0 ) 532-55753811 |
# 3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name: | Hisense LCD monitor models HMD2C21/ HMD3C21 |
|-----------------------|-------------------------------------------------------|
| Common Name: | Display system, medical image workstation, and others |
| Classification: | 892.2050 system, image processing, radiological |
| Product code: | PGY |
| Classification Panel: | Radiology |
| Device Class: | II |
### 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows: BARCO N.V., Coronis 3MP (MDCG-3221) has been cleared by FDA through 510(k) No.K131246 (Decision Date --May 24, 2013), BARCO N.V., Nio 2MP (MDNC-2221) has been cleared by FDA through 510(k) No
510(k) Summary
K133663 (Decision Date -03/25/2014)
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### 5. Description of the Device [21 CFR 807.92(a) (4)]
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a display system for medical viewing, with high resolution 1600x1200(HMD2C21)/2048 x 1536(HMD3C21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
## 6. Intended Use [21 CFR 807.92(a)(5)]
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
## 7. Technological Characteristics [21 CFR 807.92(a)(6)]
| The HMD3C21 | |
|--------------------------|----------------------------------------------------------------------------------------------------------|
| Panel | 21.2", TFT color LCD screen, antiglare |
| Brightness (typ.) | 900 cd/m² |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | 0.21075 mm |
| Native resolution | 2048 x 1536 |
| Display area | 431.6mm(H)x323.7mm (V) |
| Compatible video signals | 640 x 480@60Hz(progressive)<br>2048x1536@60Hz (progressive) |
| Horizontal resolution | 2048 x 1536 |
| Aspect ratio | 4:3 |
| Screen size | 21.2" real diagonal |
| Power | DC24V/3.5A |
| Power consumption | Max. 80 W |
| Input signals | DVI-D, Display Port |
| Digital input | TMDS (single) |
| Plug and play | VESA DDC 2B |
| Dimension | 384.0mm (W) x 492.0mm (H) x70.0mm (D) (without Stand)<br>384.0 mm (W) x 637.5 mm (H) x 273.5mm (D) (with |
#### The HMD3C21
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| | Stand ) |
|-------------------------------------------|-------------------------------------------------|
| Weight | 6.1kg (without Stand )<br>10.4kg (with Stand ) |
| Operating<br>temperature and<br>humidity: | Temperature: 0°C ~ 40°C<br>Humidity: 20% ~80% |
| Storage<br>temperature and<br>humidity: | Temperature: -20°C ~ 60°C<br>Humidity: 10% ~90% |
### The HMD2C21
| The HMD2C21 | |
|-------------------------------------------|---------------------------------------------------------------|
| Panel | 21.3", TFT color LCD screen, antiglare |
| Brightness (typ.) | 770 cd/m² |
| CR (typ.) | 1100:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | 0.27 mm |
| Native resolution | 1600 x 1200 |
| Display area | 432.0mm(H)x324.0mm (V) |
| Compatible video signals | 640 x 480@60Hz(progressive)<br>1600 x 1200@60Hz (progressive) |
| Horizontal resolution | 1600 x 1200 |
| Aspect ratio | 4:3 |
| Screen size | 21.3" real diagonal |
| Power | DC24V/3.0A |
| Power consumption | Max. 70 W |
| Input signals | DVI-D, Display Port |
| Digital input | TMDS (single) |
| Plug and play | VESA DDC 2B |
| Dimension | 384.0mm (W) x 492.0mm (H) x70.0mm (D) (without Stand) |
| | 384.0 mm (W) x 637.5 mm (H) x 273.5mm (D) (with Stand) |
| Weight | 6.1kg (without Stand) |
| | 10.4kg (with Stand) |
| Operating<br>temperature and<br>humidity: | Temperature: 0°C ~ 40°C |
| | Humidity: 20% ~80% |
| Storage<br>temperature and<br>humidity: | Temperature: -20°C ~ 60°C |
| | Humidity: 10% ~90% |
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### 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
### 8.1 Intended uses:
| ID | Comparison Item | Proposed Device<br>3MP LCD Monitor(HMD3C21) | Predicate Device<br>Nio 3MP(MDNC-3221) |
|----|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The HMD3C21 is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | "The Nio 3MP (MDNC-3221)" is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. |
### Table 1 Intended Use Comparison of HMD3C21
#### Table 2 Intended Use Comparison of HMD2C21
| ID | Comparison Item | Proposed Device<br>2MP LCD Monitor(HMD2C21) | Predicate Device<br>Nio 2MP(MDNC-2221) |
|----|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The HMD2C21 is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | "The Nio 2MP (MDNC-2221)" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. |
### 8.2 Comparison table
#### Table 3 General Comparison about HMD3C21 and Nio 3MP
| ID | Comparison<br>Item | Proposed Device<br>3MP LCD Monitor<br>(HMD3C21) | Predicate Device<br>Nio 3MP(MDNC-3221) |
|-----|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Performance | | |
| 2.1 | Panel Size and Type | 21.2", TFT LCD display | 21.3",TFT LCD display |
| 2.2 | Pixel Pitch | 0.21075 mm | 0.2115 mm |
| 2.3 | Available Cabinet<br>Colors | Red , Green , Blue | Red , Green , Blue |
| ID | Comparison Item | Proposed Device<br>3MP LCD Monitor<br>(HMD3C21) | Predicate Device<br>Nio 3MP(MDNC-3221) |
| 2.4 | Native Resolutions | 2048 x1536 | 2048 x1536 |
| 2.5 | Brightness | 900 cd/m2 | 800 cd/m2 |
| 2.6 | Contrast Ratio | 1400:1 | 1400:1 |
| 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size | 431.616mm x 323.712mm | 433.2mm x 324.9mm |
| 3 | Physical Specifications | | |
| 3.1 | Dimensions<br>(Wx Hx D) | 384.0mm (W) x 492.0mm<br>(H) x 70.0mm (D) (without<br>Stand )<br>384.0 mm (W) x<br>517.5-637.5 mm (H) x<br>273.5mm (D) (with Stand) | 375mm x 488mm x 84mm<br>(without Stand)<br>Portrait:<br>375mm x 620~520mm<br>x 235mm<br>Landscape:<br>488mm x 563~463mm<br>x 250mm<br>(with Stand) |
| | Temperature | | |
| 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 40°C |
| 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C |
| | Relative humidity | | |
| 3.4 | Operating | 20% ~80% | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 10% ~90% | 5% ~95% |
| 4 | Power Supply | | |
| 4.1 | Power Capacity | <80W | <50W |
| 4.2 | Input Voltage | DC24V/3.5A | 100~240v |
| 5 | Human factors (operation characteristic) | | |
| 5.1 | Usability | Button operation,<br>LED indicator | Button operation,<br>LED indicator |
| 5.2 | Mode of operation | Continuous operation | Continuous operation |
| 6 | Biocompatibility | | |
| 6.1 | Evaluation | The proposed device does not<br>contain any components that<br>come into direct or indirect<br>contact with patients, so the<br>evaluation doesn't be needed. | The proposed device does<br>not contain any components<br>that come into direct or<br>indirect contact with patients,<br>so the evaluation doesn't be<br>needed. |
| 7 | Sterility | | |
| 7.1 | Sterilization | The proposed device does not<br>need sterilization. | The proposed device does<br>not need sterilization. |
| 8 | Electrical & Mechanical safety& Thermal safety | | |
| 8.1 | Type of protection | Class I | Class I |
| ID | Comparison<br>Item | Proposed Device<br>3MP LCD Monitor<br>(HMD3C21) | Predicate Device<br>Nio 3MP(MDNC-3221) |
| | against electric<br>shock | | |
| 8.2 | Degree of protection<br>against harmful<br>ingress of liquid | Ordinary equipment. | Ordinary equipment. |
| 8.3 | Evaluation | The electrical, mechanical and<br>thermal safety evaluation is<br>conducted as per the<br>requirements of the standard<br>IEC 60601-1. | The electrical, mechanical<br>and thermal safety evaluation<br>is conducted as per the<br>requirements of the standard<br>IEC 60601-1. |
| 9 | Electromagnetic Compatibility | | |
| 9.1 | EMC Evaluation | Complying with<br>IEC 60601-1-2 | Complying with<br>IEC 60601-1-2 |
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### Table 4 General Comparison about HMD2C21 and Nio 2MP
| ID | Comparison<br>Item | Proposed Device<br>2MP LCD Monitor<br>(HMD2C21) | Predicate Device<br>Nio 2MP(MDNC-2221) |
|-------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Performance | | |
| 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3",TFT LCD display |
| 2.2 | Pixel Pitch | 0.27 mm | 0.27 mm |
| 2.3 | Available Cabinet<br>Colors | Red , Green , Blue | Red , Green , Blue |
| 2.4 | Native Resolutions | 1600×1200 | 1600×1200 |
| 2.5 | Brightness | 770 cd/m2 | 800 cd/m2 |
| 2.6 | Contrast Ratio | 1100:1 | 1400:1 |
| 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size<br>(H x V) | 432.0mm x324.0mm | 433.2mm x324.9mm |
| 3 | Physical Specifications | | |
| 3.1 | Dimensions<br>(W x H x D) | 384mm (W) x 492mm (H) x<br>70mm (D) (without Stand)<br>384 mm (W) x 517.5-637.5<br>mm (H) x 273.5mm (D)(with<br>Stand ) | 378mm x 491mm x 83.2mm<br>(without Stand)<br>Portrait:<br>378mm x 625~525mm<br>x 235mm<br>Landscape:<br>491mm x 565.5~465.5mm<br>x 235mm<br>(with Stand) |
| | Temperature | | |
| ID | Comparison<br>Item | Proposed Device<br>2MP LCD Monitor<br>(HMD2C21) | Predicate Device<br>Nio 2MP(MDNC-2221) |
| 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 35°C |
| 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C |
| Relative humidity | | | |
| 3.4 | Operating | 20% ~80% | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 10% ~90% | 5% ~85% |
| 4 | Power Supply | | |
| 4.1 | Power Capacity | <70W | < 50W |
| 4.2 | Input Voltage | DC24V/3A | 100~240V |
| 5 | Human factors (operation characteristic) | | |
| 5.1 | Usability | Button operation,<br>LED indicator | Button operation,<br>LED indicator |
| 5.2 | Mode of operation | Continuous operation | Continuous operation |
| 6 | Biocompatibility | | |
| 6.1 | Evaluation | The proposed device does not<br>contain any components that<br>come into direct or indirect<br>contact with patients, so the<br>evaluation doesn't be needed. | The proposed device does<br>not contain any components<br>that come into direct or<br>indirect contact with patients,<br>so the evaluation doesn't be<br>needed. |
| 7 | Sterility | | |
| 7.1 | Sterilization | The proposed device does not<br>need sterilization. | The proposed device does<br>not need sterilization. |
| 8 | Electrical & Mechanical safety& Thermal safety | | |
| 8.1 | Type of protection<br>against electric<br>shock | Class I | Class I |
| 8.2 | Degree of protection<br>against harmful<br>ingress of liquid | Ordinary equipment. | Ordinary equipment. |
| 8.3 | Evaluation | The electrical, mechanical and<br>thermal safety evaluation is<br>conducted as per the<br>requirements of the standard<br>IEC 60601-1. | The electrical, mechanical<br>and thermal safety evaluation<br>is conducted as per the<br>requirements of the standard<br>IEC 60601-1. |
| 9 | Electromagnetic Compatibility | | |
| 9.1 | EMC Evaluation | Complying with<br>IEC 60601-1-2 | Complying with<br>IEC 60601-1-2 |
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#### 8.4 Discussion of Differences:
It is reasonable that there are some differences between our new system and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).
Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images, excluding digital mammography, for review and analysis by trained medical practitioners. So the SE is not affected. Review of ID 2 - Performance, except three items as below, both are the same, so the SE is not affected.
#### About HDM3C21 and Nio 3MP
- 1. Panel Size, The proposed device is 21.2" and the predicate device is 21.3", the different of the effective display area due to the different size of the pixel pitch, and the smaller the better in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
- 2. Pixel Pitch, The proposed device is 0.21075 mm and the predicate device is 0.2115 mm, but the 0.21075 mm is better than 0.2115 mm in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
- 3. Brightness, The proposed device is 900cd/m2 and the predicate device is 700cd/m2. but the 900 cd/m2 is better than 700cd/m2 mm in terms of the bright lifetime. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 3 - Physical Specifications, Dimensions and Relative humidity are comparable, so the SE is not affected
Review of ID 4 - Power Supply, both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 5 - Human factors, both are the same, so the SE is not affected.
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Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected. Review of ID 7 - Sterility, both are the same, so the SE is not affected. Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.
Review of ID 9 - EMC, both are the same, so the SE is not affected.
#### About HDM2C21 and Nio 2MP
Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images, excluding digital mammography, for review and analysis by trained medical practitioners. So the SE is not affected.
Review of ID 2 - Performance, except two items as below, both are the same, so the SE is not affected.
- 4. Contrast Ratio, The proposed device is 1100:1 and the predicate device is 1400:1, but the different contrast ratio just affect in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
- 5. Brightness, The proposed device is 770cd/m2 and the predicate device is 800cd/m2, but the different brightness just affect in terms of the bright lifetime. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 3 - Physical Specifications, Dimensions and Relative humidity are comparable, so the SE is not affected
Review of ID 4 - Power Supply, both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 5 - Human factors, both are the same, so the SE is not affected.
Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected.
Review of ID 7 - Sterility, both are the same, so the SE is not affected.
Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.
Review of ID 9 - EMC, both are the same, so the SE is not affected.
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### 9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Qingdao Hisense Medical Equipment Co., Ltd. concludes that :
The subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device. The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no new risk is raised regarding to effectiveness and safety.
