# Makar Consulting PTY Ltd (foreign exporter, Belrose New South Wales, AU): 21 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Makar Consulting PTY Ltd |
| Owner / operator | Makar Consulting Pty Ltd |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Belrose New South Wales, AU |
| New listings | 21 |
| Devices | System, Imaging, Pulsed Echo, Ultrasonic; System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, X-Ray, Angiographic; Console, Heart-Lung Machine, Cardiopulmonary Bypass; System, X-Ray, Tomography, Computed; Full Field Digital, System, X-Ray, Mammographic; Twister, Brace Setting; Automated Radiological Image Processing Software |
| Product codes | IYO, IYN, ITX, IZI, DTQ, JAK, MUE, ITO, QIH |
| Device classes | Class I, Class II |
| Medical specialties | Radiology, Cardiovascular, Physical Medicine |
| Brand names | Vivid IQ; Philips Allura FD20; Sorin Heart Lung; GE Venue; Vivid E95; Definition Edge; Mammomat B.brilliant; Venue Go |
| First new listing | 2026-05-24 |
| Latest new listing | 2026-10-16 |
| FDA registration number | 3010703925 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.