Sony PGM-100P1MD Trinitron Color Graphic Monitor
510(k) K970999
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970999 | Date20 May 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sony PGM-100P1MD Trinitron Color Graphic Monitor is a medical-grade display designed for real-time visualization of multi-parameter patient monitoring data. It accepts standard video signals from PC-compatible systems and medical imaging devices, rendering ECG waveforms, blood pressure readings, pulse oximetry, and CT scan images in high-resolution graphic format. Classified as a radiation display device under the FDA’s product code JAK, it is engineered for clinical environments requiring precise, color-coded diagnostic output. Its Trinitron CRT technology ensures sharp contrast and accurate color reproduction, essential for critical care settings.
This monitor is intended for use in hospital ICUs, nurse stations, and other clinical areas where multi-parameter patient data must be simultaneously displayed. Supplied as a reusable, non-sterile device, it operates within standard electrical safety parameters and does not require MRI compatibility. The 13-inch CRT display is designed for wall-mounting or desktop placement, with a single-unit configuration. Authorized under FDA 510(k) clearance (K970999) as substantially equivalent to predicate devices, it adheres to regulatory standards for medical imaging displays, including radiology applications, as reviewed by the Radiology Advisory Committee.
Other devices from Sony Medical Systems
Questions
AI-generated answers, 1 Oct 2026
What is the Sony PGM-100P1MD Trinitron Color Graphic Monitor used for?
This monitor is specifically designed for real-time visualization of multi-parameter patient monitoring data in clinical settings. It renders ECG waveforms, blood pressure readings, pulse oximetry, and CT scan images with high-resolution color accuracy, making it ideal for hospital ICUs, nurse stations, and radiology applications where precise diagnostic output is critical. The Trinitron CRT technology ensures sharp contrast and reliable color reproduction, which are essential for accurate clinical assessments.
Is the Sony PGM-100P1MD Trinitron Color Graphic Monitor reusable or single-use?
The Sony PGM-100P1MD Trinitron Color Graphic Monitor is supplied as a reusable, non-sterile device. It is engineered for repeated use in clinical environments, provided it is maintained according to manufacturer guidelines to ensure continued performance and safety. Sterility is not required for this type of display device, as it does not come into direct contact with patients.
What display size and configuration does the Sony PGM-100P1MD Trinitron Color Graphic Monitor offer?
The monitor features a 13-inch CRT display and is designed for either wall-mounting or desktop placement. It operates as a single-unit configuration, meaning it is not modular or expandable. The compact size and mounting flexibility make it suitable for various clinical settings where space efficiency is important.
Does the Sony PGM-100P1MD Trinitron Color Graphic Monitor require MRI compatibility?
No, the Sony PGM-100P1MD Trinitron Color Graphic Monitor is not MRI-compatible. It is intended for use in standard clinical environments where MRI systems are not present. If MRI compatibility is required, alternative devices must be selected to ensure patient and staff safety.
How is the monitor’s regulatory status verified?
The Sony PGM-100P1MD Trinitron Color Graphic Monitor holds FDA 510(k) clearance (K970999), determined under the product code JAK (radiation display device). It was reviewed by the Radiology Advisory Committee (RA) and classified as substantially equivalent to predicate devices. This clearance confirms its compliance with U.S. regulatory standards for medical imaging displays, ensuring its suitability for clinical use in radiology and patient monitoring applications.