(15 days)
None
No
The document describes a medical display system and does not mention any AI or ML capabilities. The focus is on display technology and image processing in a general sense, not AI-driven analysis.
No
The device is a display system for medical images, intended for review and analysis by medical practitioners, and does not directly provide therapy.
No
The device is a display system used for viewing and analyzing digital images, not for making a diagnosis itself. It presents information that practitioners use to diagnose.
No
The device description explicitly details hardware components like an LCD display, brightness stabilization circuit, front sensor, ambient light sensor, and a protective screen.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The G52SP+/G52S+ 5MP Grayscale LCD Display is a display system used for viewing and analyzing digital medical images. It does not perform any tests on biological samples.
- Intended Use: The intended use is to display and view digital images for review and analysis by medical practitioners. This is a display function, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the technical specifications of the display for image viewing.
- Mentions image processing: While it mentions image processing, this refers to the processing of the digital image data for display, not the processing of a biological sample.
Therefore, the G52SP+/G52S+ 5MP Grayscale LCD Display falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The G52SP+/G52S+ 5MP Grayscale LCD Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Product codes
LLZ
Device Description
The G52SP+/G52S+ 5MP Grayscale LCD display is a display system for medical viewing, with high resolution 2560 x 2048, 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 anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
Mentions image processing
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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. The text at the top reads "K132610". Below that, the text reads "Page 1 of 1". At the bottom, the text reads "510(k) Submission".
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
December 24, 2012
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: | 5MP Grayscale 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:
Barcoview, Nio 5MP-21" has been cleared by FDA through 510(k) No.K062621 (Decision Date -Mar 19, 2007),
1
5. Description of the Device [21 CFR 807.92(a) (4)]
The G52SP+/G52S+ 5MP Grayscale LCD display is a display system for medical viewing, with high resolution 2560 x 2048, 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 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 G52SP+/G52S+ 5MP Grayscale LCD Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
| Panel | 21.3", TFT monochrome LCD screen, antigalre |
|---|---|
| Brightness (typ.) | 1200 cd/m² |
| CR (typ.) | 1200:1 |
| Viewing angle | R/L 170°, U/D 170° Typ. (CR > 20) |
| Pixel Pitch | 0.165 mm |
| Native resolution | 2560 x 2048 |
| Display area | 422.4mm(H)x337.92mm (V) |
| Compatible video | 640 x 480@60Hz(progressive) |
| signals | 2560 x 2048@50Hz(progressive) |
| Horizontal resolution | 2560 x 2048 |
| Bandwidth |