Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging S…
FDA 510(k)Class II (US FDA 510(k))
by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Identifiers
- 510(k) Number
- K160853 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Apogee 5500/Apogee 5300/Apogee 5800 Digital Color Doppler Ultrasound Imaging System is a diagnostic ultrasound device used for imaging and evaluating anatomical structures and blood flow. It is classified under product code IYN and falls within the Radiology medical specialty as defined by the FDA.
The system was cleared through the FDA 510(k) process under K160853 with a traditional clearance type and a substantially equivalent decision issued on June 27, 2016. It is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) and is intended for use by qualified physicians in clinical ultrasound evaluation.
Frequently asked questions
What is the Apogee 5500/5300/5800 Digital Color Doppler Ultrasound Imaging System used for?
It is used for imaging and evaluating anatomical structures and blood flow in clinical settings, intended for use by qualified physicians in diagnostic ultrasound evaluations as a diagnostic ultrasound device.
How was the Apogee 5500/5300/5800 ultrasound system cleared for market release?
It received FDA 510(k) clearance under K160853 through a traditional submission process, with a substantially equivalent decision issued on June 27, 2016, based on its comparison to legally marketed predicate devices.
Who manufactures the Apogee 5500/5300/5800 Digital Color Doppler Ultrasound Imaging System?
The system is manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), located at 77 Jinsha Rd., Shantou, China, with postal code 515041.
What product code and medical specialty classification does the Apogee 5500/5300/5800 ultrasound system fall under?
It is classified under FDA product code IYN and is part of the Radiology medical specialty, as defined in its FDA 510(k) submission and clearance documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound ..., Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color… - FDA.report, Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160853 | Class II | Active |
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Manufacturer
Sources (1)
- FDA 510(k) K160853 24 fields · synced Oct 6, 2026