MiroCam Capusle Endoscope System
MiroCam Capsule Endoscope System images the small bowel lining in adults. The MC2000-B capsule captures images as it travels through the gastrointestinal tract, and an MR2000 receiver…
MiroCam Capsule Endoscope System images the small bowel lining in adults. The MC2000-B capsule captures images as it travels through the gastrointestinal tract, and an MR2000 receiver stores them for later review by a gastroenterologist.
The capsule uses a CMOS image sensor and twelve white LEDs. Image data are carried by a weak electrical signal through body tissues and fluids to sensor pads on the abdomen. Cables connect the pads to the receiver worn by the patient.
Listed Item
Package System(MC2000-B Capsule and MR2000 Receiver)
Image Review
After the procedure, the receiver connects to a computer by USB to upload the images. MiroView software supports review of the recorded data for suspected small-bowel abnormalities.
Who Else Makes It
Registered in Hubei. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Technologies Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 2 |
Record
| Listed by | IntroMedic Co., Ltd., South Korea |
|---|---|
| FDA product code | NEZ |
| Device type | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K170438 |
| Record published | 2018-02-12 |
| Record revised | 2020-08-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Large box, large box of 16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MC2000-B, MR2000 | In distribution | ||
| MC2000-B | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pillcam | Given Imaging Ltd. | 65 |
| Rapid | Given Imaging Ltd. | 21 |
| MiroCam Capsule Endoscope System | IntroMedic Co., Ltd. | 15 |
| PillCam | Covidien LP | 9 |
| NaviCam Small Bowel Capsule Endoscopy System | Ankon Technologies Co., Ltd. | 5 |
| System, Imaging, Gastrointestinal, Wireless, Capsule | Given Imaging Ltd. | 3 |
| PillCam Genius | Given Imaging Ltd. | 3 |
| AdvanCE | Us Endoscopy | 2 |
| CapsoCam Plus | CapsoVision, Inc. | 2 |
| CapsoRetrieve | CapsoVision, Inc. | 2 |
| CapsoView | CapsoVision, Inc. | 1 |
| NaviCam Data Recorder | ANX Robotica Corp. | 1 |
Showing 12 of 44. All products under System, Imaging, Gastrointestinal, Wireless, Capsule
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252617 | 2026-05-08 |
| K180732 | 2018-11-08 |
| K170438 | 2018-01-30 |
| K143663 | 2015-03-17 |
| K134005 | 2014-07-09 |
| K140751 | 2014-06-30 |
| K123428 | 2013-05-20 |
| K111450 | 2012-05-18 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-02-15 | Class II | Device Design | When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage. | 82 | 2018-08-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.