Model note · MCCE
Olympus Endocapsule 10 System
The Endocapsule 10 System is Olympus's small intestine capsule endoscope. A single use capsule passes by peristalsis and transmits images to an eight element antenna sheet and a recorder worn by the patient; the recorder then docks in a cradle to download into Endocapsule Software 10 on a workstation. In the US it is cleared for adults to look for bleeding sources, Crohn's lesions and causes of iron deficiency anaemia missed by standard endoscopy.
The model
Maker, model and type.
- Maker
- Olympus Medical Systems Corp.
- Model
- Endocapsule 10 System (EC-10 capsule, RE-10 recorder, Endocapsule Software 10)
- Device type
- MCCE
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Capsule size (EC-Y0006 design, carried into EC-10) | 11 mm outer diameter, 26 mm long | Source |
| Illumination and optics | Four white LEDs around a compact objective lens under a clear top cover | Source |
| Radio link | 315 MHz transmitter in the capsule | Source |
| Capsule power | Two silver oxide batteries; mercury free cells from the EC-10 (K163069) | Source |
| Antenna unit | Integrated antenna sheet with eight antenna elements, worn at the waist in an antenna holder (a lead type antenna was added later) | Source |
| System components (K183053) | Capsule set MAJ-2027, recorder set MAJ-2029 with RE-10 recorder, battery pack, antenna unit, cradle, holders, capsule activator MAJ-1478, software MAJ-2188 and MAJ-2189 | Source |
| Intended population (US) | Adults only | Source |
| Software level of concern | Moderate | Source |
| FDA clearance (current system) | K183053, decided 5 March 2019, product code NEZ, 21 CFR 876.1300 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Sources
Where this note comes from.
- FDA 510(k) K183053 summary, Olympus Small Intestinal Capsule Endoscope System
- FDA 510(k) K173459 summary, lead type antenna
- FDA 510(k) K163069 summary, EC-10 mercury free batteries
- FDA 510(k) K142680 summary, Endocapsule Software 10
- FDA 510(k) K123421 summary, earlier system with capsule design details
- openFDA MAUDE problem counts, brand ENDOCAPSULE
Not covered: Endocapsule is a passive capsule, not magnetically controlled; it is included as a widely installed capsule system in this family. Capsule size, LEDs and the 315 MHz link come from the 2013 summary; K163069 says the EC-10 is otherwise identical, but frame rate, field of view and battery life were not found in a public document. No openFDA recall matched the Endocapsule. The instruction manual was not reached, so no recorder messages or error codes are given; the manufacturerUrl is the Olympus corporate site, not a product page.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
MCCE