# 8C-Rs

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/8c-rs-h40402ls>
- Manufacturer: [GE Healthcare Japan Corporation](https://devicerts.com/manufacturers/fda-fei-3002808529) (Japan)
- Name in the registry: 8C-RS
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: IYN, IYO, ITX
- EMDN: Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY)
- GMDN: Extracorporeal ultrasound imaging transducer, hand-held (40768)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 8406821BUG00225H6 · UDI-DI 00840682106962 · registered 2026-02-06 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00840682106962 · listed 2016-07-15 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K160184 · issued 2016-02-25 · status: Active · from GUDID

## Recalls

- Z-0865-2024 · Class II · ongoing · initiated 2023-12-22: GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.

## Identity

- Generic name: Extracorporeal ultrasound imaging transducer, hand-held [FDA GUDID (AccessGUDID)]
- Model / reference: 2354973 [EUDAMED]; H40402LS [EUDAMED]; 8C-RS [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00840682106962 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 8406821BUG00225H6 [EUDAMED]
- Direct marketing DI: 00840682106962 [EUDAMED]
- 510(k) Number: K160184 [FDA GUDID (AccessGUDID)]
- FDA product code: IYN [FDA GUDID (AccessGUDID)]; IYO [FDA GUDID (AccessGUDID)]; ITX [FDA GUDID (AccessGUDID)]
- EMDN code: Z110402010201 [EUDAMED]
- GMDN term: Extracorporeal ultrasound imaging transducer, hand-held (40768) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.1550 [FDA GUDID (AccessGUDID)]; 892.1560 [FDA GUDID (AccessGUDID)]; 892.1570 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: France [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: 8C-Rs, GE Healthcare Japan Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/8c-rs-h40402ls (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/8c-rs-h40402ls.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/8c-rs-h40402ls
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.