Model note · MCCE
Medtronic PillCam SB 3 capsule endoscopy system
PillCam SB 3 is a single use, swallowed video capsule for imaging the small bowel mucosa. It is not magnetically steered: it moves by normal peristalsis and sends images by radio to a DR3 recorder worn on a sensor belt or array, and PillCam Software on a workstation turns the images into a video for review and reporting. It is used to look for sources of obscure bleeding, Crohn's lesions and causes of iron deficiency anaemia missed by standard endoscopy.
The model
Maker, model and type.
- Maker
- Given Imaging Ltd. (Medtronic)
- Model
- PillCam SB 3 capsule endoscopy system (capsule, DR3 recorder, PillCam Software 9)
- Device type
- MCCE
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Capsule length and diameter | 26.2 mm by 11.4 mm | Source |
| Capsule weight | 3.0 g | Source |
| Power source | 2 mercury free silver oxide batteries | Source |
| Optics | One optical head, 156 degree field of view (ISO 8600-3), effective visibility 0 to 30 mm | Source |
| Frame rate | 2 fps fixed, or adaptive 2 to 6 fps | Source |
| Operating time | Minimum of 8 hours | Source |
| Minimum detectable object | At least 0.07 mm | Source |
| Intended population | Adults and children from two years of age | Source |
| First FDA clearance | K123864, PillCam SB 3 with RAPID 8.0, product code NEZ, class II under 21 CFR 876.1300 (later K211684 and K230991) | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Until the capsule has been passed, the patient must stay away from strong electromagnetic fields such as those near an MRI scanner. Source
- Listed risks include capsule retention, aspiration and skin irritation, and medical, endoscopic or surgical intervention may be needed to deal with them. Source
- The Suspected Blood Indicator only marks frames suspected of containing blood or red areas; it is an aid, not a diagnosis. Source
Sources
Where this note comes from.
- FDA 510(k) K211684 summary, PillCam SB 3 with PillCam Software 9.0E
- FDA 510(k) K230991 summary, PillCam Cloud Reader
- FDA 510(k) K123864 summary, PillCam SB 3 with RAPID 8.0
- Medtronic PillCam SB 3 indications and safety (New Zealand)
- openFDA MAUDE problem counts, brand PILLCAM SB3
Not covered: PillCam SB 3 is a passive capsule, not a magnetically controlled one; it is included as the widely installed reference capsule system for this device family. The user manual sits behind Medtronic's manuals portal and was not read, so no recorder error messages, battery checks or part numbers are given. The US safety page did not render for text extraction; the New Zealand page was used and risk lists differ by region. No FDA recall matched the SB 3 itself.
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.