Sirecust 420 Patient Dialog Monitor
by Siemens Medical Solutions USA, Inc.
510(k) K851400
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851400 | Date26 Jun 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sirecust 420 Patient Dialog Monitor is a Display, Cathode-Ray Tube, Medical device designed for patient communication and monitoring in clinical settings. It facilitates real-time interaction between healthcare providers and patients, enabling dialogue and feedback during medical procedures, particularly in cardiovascular care. The device integrates visual and auditory cues to enhance patient engagement and support procedural workflows.
This monitor is supplied as a reusable medical device, intended for use in hospital or clinical environments where patient communication is critical. It operates under regulatory oversight as a Class II device under FDA regulation 870.2450, with a 510(k) clearance (K851400) granted in 1985. The device is not classified as MRI-safe or MRI-conditional, and no specific sterility requirements are noted in the regulatory data. Storage and handling follow standard medical device protocols for reusable equipment.
Other devices from Siemens Medical Solutions USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Sirecust 420 Patient Dialog Monitor used for?
The Sirecust 420 Patient Dialog Monitor is designed to facilitate real-time interaction between healthcare providers and patients during medical procedures, particularly in cardiovascular care. It integrates visual and auditory cues to improve patient engagement and support procedural workflows by enabling dialogue and feedback.
Is the Sirecust 420 Patient Dialog Monitor reusable or single-use?
The Sirecust 420 Patient Dialog Monitor is supplied as a reusable medical device. It is intended for use in hospital or clinical environments where patient communication is critical, following standard protocols for reusable medical equipment.
What regulatory classification does the Sirecust 420 Patient Dialog Monitor hold?
The Sirecust 420 Patient Dialog Monitor is classified as a Class II device under FDA regulation 870.2450. It received a 510(k) clearance (K851400) in 1985, with a decision of 'Substantially Equivalent' by the Cardiovascular Advisory Committee.
Does the Sirecust 420 Patient Dialog Monitor have specific sterility requirements?
The regulatory data for the Sirecust 420 Patient Dialog Monitor does not specify any particular sterility requirements. As a reusable device, it follows standard medical device protocols for cleaning, disinfection, and maintenance.
Is the Sirecust 420 Patient Dialog Monitor MRI-safe or MRI-conditional?
The Sirecust 420 Patient Dialog Monitor is not classified as MRI-safe or MRI-conditional. This means it should not be used in MRI environments, as its compatibility with magnetic resonance imaging has not been established.