MiroCam Capsule Endoscope System
MiroCam Capsule Endoscope System visualizes small-bowel mucosa in adults and children aged two years or older. A swallowed MC1000-B capsule captures images and sends them through body…
MiroCam Capsule Endoscope System visualizes small-bowel mucosa in adults and children aged two years or older. A swallowed MC1000-B capsule captures images and sends them through body tissues and fluids to abdominal sensor pads connected to an MR1100 receiver.
The capsule uses a CMOS sensor and six white LEDs to acquire three images per second for at least 12 hours. Images are stored by the receiver and transferred to a computer for physician review.
Listed Item
Package System(MC1000-B Capsule and MR1100 Receiver)
Review Functions
MiroView software supports uploading and reviewing the recorded images. The suspected gastrointestinal bleeding indicator marks frames that may contain blood or red areas. Real-time viewing can also be provided through the receiver’s wired or wireless interface.
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) | K140751 |
| Record published | 2017-01-31 |
| Record revised | 2020-08-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Large box of 20, large box, large box of 16, large box of 3, pack of 100, large bos of 3 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MR1100 | In distribution | ||
| MC1200-B | 10 | In distribution | |
| MC1200-B, MR2000 | In distribution | ||
| MR1000-D(M) | In distribution | ||
| MC1000-B, MR1100 | In distribution | ||
| MR1000-D(L) | In distribution | ||
| MC2000-B | 10 | In distribution | |
| MR2000 | In distribution | ||
| MC1000-B | 5 | In distribution | |
| MR1000-S | In distribution | ||
| MC1200-B, MR1100 | In distribution | ||
| MC1600-B | 5 | In distribution | |
| MC1200-B | 5 | In distribution | |
| MC1600-B, MR2000 | In distribution | ||
| MC1600-B | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pillcam | Given Imaging Ltd. | 65 |
| Rapid | Given Imaging Ltd. | 21 |
| 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 |
| MiroCam Capusle Endoscope System | IntroMedic Co., Ltd. | 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.