(30 days)
Not Found
No
The description focuses on the display's hardware features and image display capabilities, with no mention of AI/ML algorithms for image analysis or processing beyond basic display functions.
No
This device is a display system for viewing digital images and does not directly treat or diagnose a medical condition. It is intended to assist medical practitioners in their review and analysis of images.
No
This device is a display system used to view medical images, not a device that performs diagnosis itself.
No
The device description clearly states it is a "display system" and mentions hardware components like an LCD display, brightness stabilization circuit, ambient light sensor, and protective screen. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display and view digital images for review and analysis by medical practitioners. This is a display device for medical imaging, not a device that performs tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the technical specifications of a display system (resolution, brightness, etc.) for viewing images. It does not mention any components or processes related to analyzing biological samples.
- Mentions image processing: While it mentions image processing, this is in the context of displaying radiological images, not processing biological samples.
- No mention of biological samples or testing: There is no indication that this device interacts with or analyzes any biological materials (blood, urine, tissue, etc.).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is solely to display medical images.
N/A
Intended Use / Indications for Use
The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The G32SP+/G32S+ 3MP Grayscale LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The C32SP+/C32S+ 3MP Color LCD Display is a display system for medical viewing, with high resolution 2048 x 1536, built-in brightness stabilization circuit and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
Image /page/0/Picture/1 description: The image shows handwritten text on a white background. The text includes "K140103" on the top line, followed by "Page 1 of 6" on the second line. The bottom left corner has the text "510(k) Submission".
510(k) Summary
FEB 1 4 2014
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
December 24, 2013
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd |
|---|---|
| Address: | Room 201, Incubator Building, CASTD, High-tech South 1st |
| street, Nanshan District, Shenzhen 518057, China | |
| Contact Name: | Wu Qin |
| Telephone No.: | +86 755 26995355 |
| Fax No.: | +86 755 26995755 |
| Email Address: | wuqin@beacon-display.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a)
(2)]
| Trade Name: | 3MP Color LCD Display |
|---|---|
| Common Name: | Display system, medical image workstation, and others |
| Classification: | 892.2050 system, image processing, radiological |
| Product code: | LLZ |
| 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., Nio Color 3MP LED has been cleared by FDA through 510(k) No.K131295 (Decision Date -May 29, 2013),
1
5. Description of the Device [21 CFR 807.92(a) (4)]
The C32SP+/C32S+ 3MP Color LCD Display is a display system for medical viewing, with high resolution 2048 x 1536, built-in brightness stabilization circuit and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
6. Intended Use [21 CFR 807.92(a)(5)]
The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
| Panel | 21.3", TFT monochrome LCD screen, antiglare |
|---|---|
| Brightness (typ.) | 1700 cd/m² |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | 0.2115mm |
| Native resolution | 2048 x 1536 |
| Display area | 433.152mm(H) x 324.864mm(V) |
| Compatible video signals | 640 x 480@60Hz(progressive) |
| 2048x1536@60Hz(progressive) | |
| Horizontal resolution | 2048 x 1536 |
| Bandwidth | 216MHz |
| Aspect ratio | 4:3 |
| Screen size | 21.3" real diagonal |
| Power | DC12V/7.0A |
| Power consumption | Max. 80 W |
| Input signals | DVI-D, Display Port |
| Digital input | TMDS ( single ) |
| Plug and play | VESA DDC 2B |
| Dimension | 369.0mm (W) x 482.6mm (H) x 63.6mm (D) (without Stand ) |
| 369.0 mm (W) x 626.6 mm (H) x 234.8mm (D) (with Stand ) |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
2
| Weight | 6.5kg (without Stand)
9.5kg (with Stand) |
|-------------------------------------------|------------------------------------------------|
| Operating
temperature and
humidity: | Temperature: 0°C ~ 40°C
Humidity: 15%~85% |
| Storage
temperature and
humidity: | Temperature: -20°C ~ 60°C
Humidity: 10%~90% |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
Table 1 Intended Use Comparison
| ID | Comparison
Item | Proposed Device
C32SP+/C32S+ | Predicate Device
Nio Color 3MP LED |
|----|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended
Use | The C32SP+/C32S+ 3MP Color
LCD Display is intended to be
used in displaying and viewing
digital images (excluding digital
mammography) for review and
analysis by trained medical
practitioners. | "Nio Color 3MP LED" 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. |
8.2 Comparison table
Table 2 General Comparison
| ID | Comparison
Item | Proposed Device
C32SP+/C32S+ | Predicate Device
Nio Color 3MP LED |
|-----|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Performance | | |
| 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3", TFT LCD display |
| 2.2 | Pixel Pitch | 0.2115 mm | 0.2115 mm |
| 2.3 | Available Cabinet
Colors | Black | Black |
| 2.4 | Native Resolutions | 2048 x1536 | 2048 x1536 |
| 2.5 | Brightness | 1700 cd/m2 | 1700 cd/m2 |
| 2.6 | Contrast Ratio | 1400:1 | 1300:1 |
| 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size | 433.152mm x324.864mm | 433.2mm x324.9mm |
| 3 | Physical Specifications | | |
| 3.1 | Dimensions
(Wx Hx D) | 369.0mm (W) x 482.6mm (H) | 375mm x 488mm x 84mm
(without Stand) |
| ID | Comparison Item | Proposed Device
C32SP+/C32S+ | Predicate Device
Nio Color 3MP LED |
| | | x 63.6mm (D) (without Stand) | Portrait:
375mm x 620520mm463mm
x 235mm |
| | | 369.0 mm (W) x 626.6 mm (H)
x 234.8mm (D) (with Stand) | Landscape:
488mm x 563
x 250mm
(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 | 15% ~85% | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 10%~90% | 5% ~95% |
| 4 | Power Supply | | |
| 4.1 | PowerCapacity |