HOROS MD
Basic Information
- Brand Name
- HOROS MD
- Primary DI
- 05070002336808
- Version / Model
- HOROS MD
- Company Name
- ICAT SOLUTIONS LTD
- Labeler DUNS
- 219621409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-20
- Public Version
- 1
- Public Version Date
- 2024-01-29
- Public Version Status
- New
- Public Device Record Key
- 537f29f3-0abe-40ac-861a-8ae822361faf
Device Description
The Horos MD™ is an interactive image display and navigation software device for diagnosis of medical images. It provides both 2D and 3D image visualization tools for CT and MRI scans from different makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. Horos MD™ conforms to the DICOM standard to allow the sharing of medical images with other digital imaging systems such as PACS (Picture Archiving and Communication System). The Horos MD™ software device runs on the macOS X platform, taking advantage of its optimized 3D graphic capabilities, which are provided by the METAL framework developed and maintained by Apple Inc. The user interface of the software follows Apple's Human Interface Guidelines (HIG) in order to create a user interface that is intuitive and easy to use for users who are familiar with other Apple products. Typical users of this device are radiologists and clinicians who are familiar with 2D scan images.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40943 | Radiology picture archiving and communication system workstation | A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05070002336808 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232589 | 000 |