Image Management System (K033870)
510(k) K033870
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033870 | Date12 Mar 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Image Management System
- 510(k) Number
- FDA product code
- HEX
- Device class
- Class II
- Regulation
- 21 CFR Part 884.1630
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Image Management System is a digital imaging solution designed for colposcopy procedures, enabling capture, display, storage, export, and printing of video images from a colposcope. Classified as a colposcope (and colpomicroscope) under FDA classification HEX, it facilitates integration with diagnostic workflows in obstetrics and gynecology settings. The system digitizes video signals via a third-party DV converter, transmitting them to a computer for further processing and archival.
This device is intended for use in clinical environments where colposcopic imaging is performed, supporting single-use or reusable colposcope attachments as specified by the manufacturer. Supplied as a software-hardware combination, it requires connection to a compatible colposcope via S-video and a computer via IEEE 1394B interface. The system is FDA-cleared under 510(k) number K033870, with regulatory alignment to 21 CFR 884.1630, and is intended for obstetrics/gynecology applications. Storage and backup procedures are documented in user manuals, ensuring compliance with clinical documentation standards.
Other devices from Welch Allyn, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Welch Allyn Image Management System used for?
The Welch Allyn Image Management System is designed specifically for colposcopy procedures in obstetrics and gynecology settings. It digitizes video signals from a colposcope, enabling capture, display, storage, export, and printing of images. This integration with diagnostic workflows helps clinicians document and analyze colposcopic findings more efficiently.
How is the Image Management System supplied and what connections does it require?
The system is supplied as a software-hardware combination. It requires connection to a compatible colposcope via an S-video interface and to a computer via an IEEE 1394B (FireWire) interface. These connections allow the system to transmit video signals for processing and archival.
Is the Image Management System single-use or reusable?
The Image Management System itself is not single-use or reusable—it is a hardware/software solution intended for repeated use in clinical settings. However, it is designed to integrate with either single-use or reusable colposcope attachments, depending on the manufacturer’s specifications for the colposcope being used.
What regulatory approval does the Image Management System hold?
The Welch Allyn Image Management System holds FDA 510(k) clearance under the reference number K033870. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and is intended for use in obstetrics/gynecology applications under 21 CFR 884.1630.
How are images stored and backed up in the system?
The system’s storage and backup procedures are documented in the user manuals provided by Welch Allyn. These guidelines ensure compliance with clinical documentation standards, allowing clinicians to securely archive and retrieve colposcopic images as needed for patient care and record-keeping.