# Sector Probe S4-2 A7CA

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

- Canonical page: <https://devicerts.com/devices/sector-probe-s4-2-a7ca>
- Manufacturer: [Konica Minolta, Inc.](https://devicerts.com/manufacturers/konica-minolta-inc) (Japan)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: ITX, IYO
- EMDN: Z110402010301 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL
- GMDN: Extracorporeal ultrasound imaging transducer, hand-held (40768)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 4560141920000598S · UDI-DI 04560141940185 · registered 2026-07-02 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 04560141940185 · listed 2016-09-19 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K151060 · decision 2015-06-05 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1215-2018 · Class II · terminated · initiated 2017-12-04 · matched through shared submission K151060, may concern other models: There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.

## Identity

- Trade name: Sector Probe S4-2 [FDA GUDID (AccessGUDID)]
- Generic name: Extracorporeal ultrasound imaging transducer, hand-held [FDA GUDID (AccessGUDID)]
- Model / reference: SECTOR PROBE S4-2 [EUDAMED]; S4-2 [EUDAMED]; A7CA [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 04560141940185 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 4560141920000598S [EUDAMED]
- Direct marketing DI: 04560141940185 [EUDAMED]
- 510(k) Number: K151060 [FDA GUDID (AccessGUDID)]
- FDA product code: ITX [FDA GUDID (AccessGUDID)]
- EMDN code: Z110402010301 [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: 892.1570 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: 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)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Sector Probe S4-2 A7CA, Konica Minolta, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/sector-probe-s4-2-a7ca (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/sector-probe-s4-2-a7ca.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/sector-probe-s4-2-a7ca
- 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.