Calysto Image IV-Image and Information Management System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K040195 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Calysto Series IV Patient Care Monitors and Central Station and ECG Management System

  Class II

  FDA 510(k) K033030 Active Cleared 24 Feb 2004

• Witt Biomedical Series II-Ep

  Class II

  FDA 510(k) K923054 Active Cleared 25 Feb 1993

• Calysto Series IV Physio-Monitoring and Information System

  Class II

  FDA 510(k) K063547 Active Cleared 21 Dec 2006

• Witt Biomedical Vx-80

  Class II

  FDA 510(k) K880258 Active Cleared 16 Jun 1988

• Image IV DICOM Image Archival PACS Network

  Class II

  FDA 510(k) K010058 Active Cleared 21 Mar 2001

• Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient Care Monitoring Units

  Class II

  FDA 510(k) K973474 Active Cleared 13 Mar 1998

See all devices from Witt Biomedical Corp →

• What is the Calysto Image IV-Image and Information Management System used for?

  The Calysto Image IV is designed to digitize, store, and facilitate the review of radiographic images by radiologists and trained practitioners. It enhances diagnostic capabilities by enabling efficient interpretation of medical images, supporting better disease detection and patient management in radiology settings.

• Is the Calysto Image IV a single-use or reusable device?

  The Calysto Image IV is supplied as a reusable device. It is not designated for single-use and is intended for long-term use in radiology departments, adhering to regulatory standards for radiological image processing systems.

• What regulatory approval does the Calysto Image IV hold?

  The Calysto Image IV has received FDA 510(k) clearance under K-number K040195, classified as substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. regulatory standards for radiological image processing systems.

• Does the Calysto Image IV require any special storage conditions?

  Storage and operational requirements for the Calysto Image IV are outlined in the manufacturer’s instructions for use. While no specific sterility or single-use designation applies, proper handling and maintenance as per guidelines ensure optimal performance and longevity of the system.

• Is the Calysto Image IV compatible with MRI environments?

  The Calysto Image IV is not designed with MRI safety considerations, meaning it is not intended for use in MRI environments or near MRI equipment. Always follow manufacturer guidelines to ensure safe and appropriate usage.