iCRco Inc.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• ICRCO CLARITY VIEWER

  2014-01-21

  ICRCO INC.

• ICRCO 3600M

  2013-04-26

  ICRCO INC.

• CLARISCT

  2012-07-26

  ICRCO INC.

• FUSION FLAT PANEL

  2012-06-14

  ICRCO INC.

• IDR

  2009-06-30

  ICRCO INC.

GUDID#

• iCRco Clarity Viewer - Clarity Viewer with ClarityPACS archive is a medical image viewing and archiving software system designed to retrieve, store, display, and distribute digital radiology images and data across local and cloud computer networks. The system includes image manipulation, markup tools, and a structured report writer for primary image diagnostic interpretation.

  IcRco, Inc.

  2026-07-22

• 3600 - A compact, single-plate small format computed radiography (CR) scanner designed for general radiography, orthopedics, and mobile imaging. Features a patented True Flat Scan Path to eliminate roller damage and preserve diagnostic image quality.

  IcRco, Inc.

  2026-07-22

• AirDR - AirDR G3+ is a 17X17 (430X430 mm) solid-state, large-format Digital Radiography (DR) Flat Panel X-ray Detector designed for integration into general-purpose diagnostic x-ray imaging systems. The device operates as a direct-replacement technology for conventional film-screen cassettes or computed radiography (CR) plates within existing or new medical radiography systems

  IcRco, Inc.

  2026-07-22

• iXRS - The iXRS is a integrated digital radiography X-ray suite consisting of an FDA-compliant stationary X-ray room and generator, seamlessly configured with the iCRco AirDR-G3+ digital imaging receptor panel and XC acquisition software. This system functions as a complete diagnostic imaging solution designed to acquire, process, and view diagnostic medical X-ray images

  IcRco, Inc.

  2026-07-22

• CLARIS - The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.

  IcRco, Inc.

  2026-07-22

• iDR - The iCRco iDR-34 is a cassette-less, stationary digital radiography (DR) system capable of regional scanning and long-length skeletal imaging. It features an integrated 17” x 34” active area scanning detector panel utilizing internal phosphor plate technology. The system provides a single-exposure, stitch-free imaging workflow for full-torso and spinal applications, eliminating the need for stitching software. It incorporates a 16-bit grayscale resolution scan processor and operates via proprietary X-Ray Capture (XC) acquisition software

  IcRco, Inc.

  2026-07-22

• iDR - The iCRco iDR-L is a cassette-less, stationary digital radiography (DR) long-bone and full-spine imaging system. It features an integrated 17” x 51” (or 14” x 51”) active area scanning detector panel utilizing internal phosphor plate technology. The system is designed for single-exposure, upright, stitch-free long-length skeletal imaging, operating via a motorized vertical wall-mount lift. It incorporates a 16-bit grayscale resolution scan processor and operates via proprietary X-Ray Capture (XC) acquisition software

  IcRco, Inc.

  2026-07-22

• 3600 - The iCR-3600LF (Large Format) by ICRco is a rugged, heavy-duty Computed Radiography (CR) scanner engineered for high-volume environments. Designed for human markets—including general radiology, orthopedics, and pediatrics—it utilizes patented, roller-free True Flat Scan Path (tm) technology to deliver artifact-free imaging while significantly extending the lifespan of phosphor plates

  IcRco, Inc.

  2026-07-22

• 3600 - The iCR 3600M is a digital mammography computed radiography (CR) scanner manufactured by iCRco. It utilizes True Flat Scan Path technology to read phosphor plates without rollers, paired with ICE-M image processing algorithms designed specifically for mammography in addition to general radiography application

  IcRco, Inc.

  2026-07-22

• CHROME - The iCRco Chrome LF is a high-resolution, tabletop computed radiography (CR) system designed for general digital radiography and orthopedic imaging. It utilizes a patented True Flat Scan Path technology that scans phosphor plates without internal rollers, reducing wear and extending plate longevity. The device supports standard 10x12 and 14x17 inch cassettes, delivers up to 16-bit grayscale image resolution, and interfaces with DICOM-compliant imaging networks

  IcRco, Inc.

  2026-07-22

• AirDR - The AirDR-LE by iCRco is a cassette-sized, 140-micron flat-panel detector designed to easily upgrade existing X-ray systems to digital radiography (DR). It features wireless connectivity, Automatic Exposure Detection (AED), and a Gadox scintillator, delivering high-resolution imaging at the lowest possible dose.

  IcRco, Inc.

  2026-07-22

• AirDR - Wireless/Tethered 14X17 inch (430X340 mm) Digital X-ray Flat Panel Detector (FPD) used to capture radiographic images. Features Automatic Exposure Detection (AED), 139 micron pixel pitch, and direct deposition Cesium Iodide (CsI) scintillator technology. Designed for general radiographic procedures and mobile X-ray integration.

  IcRco, Inc.

  2026-07-22