OptoMonitor 3
OptoMonitor 3 is the monitoring and display equipment used with Opsens OptoWire pressure guidewires. Together they measure pressure in coronary or peripheral blood vessels and provide…
OptoMonitor 3 is the monitoring and display equipment used with Opsens OptoWire pressure guidewires. Together they measure pressure in coronary or peripheral blood vessels and provide hemodynamic information such as fractional flow reserve.
The non-patient-contact assembly includes an Optical Unit, Display Unit and Handle Unit, with connecting cables and power accessories. The guidewire supplies the vascular pressure interface, while the monitor equipment handles the measurement display.
Communication and Display
Optical and Display units can communicate by Bluetooth, with a wired connection available as backup. The range includes a 10-inch display option and software for reviewing pressure recordings, providing different equipment configurations around the pressure-guidewire system.
4manufacturers in China registered for this device type
73catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Opsens Inc., Canada |
|---|---|
| FDA product code | DXO |
| Device type | Transducer, Pressure, Catheter Tip |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2870 |
| Establishment | Manufacturer |
| 510(k) | K202943 |
| Record published | 2016-09-24 |
| Record revised | 2026-05-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC Power cord C13 to P5 15P HG NA | In distribution | |
| Pressure output cable – Philips/WITT | In distribution | |
| OpM3 OU-DU RS-232 comm cable | In distribution | |
| OpM3-DU Power Supply Cable | In distribution | |
| AO cable – Siemens Recor | In distribution | |
| Pressure output cable – Fukuda Denshi FC | In distribution | |
| AO cable – Schwarzer Cardis 5000 | In distribution | |
| Pressure output cable – Mennen Model 267 | In distribution | |
| OpM3 Display Unit 10″ | In distribution | |
| AO cable – Nihon Koden | In distribution | |
| Pressure output cable – Siemens Sensis | In distribution | |
| AUX interface cable – Siemens Axiom | In distribution | |
| Pressure output cable – Siemens Recor | In distribution | |
| AO cable – BARD Clearsign | In distribution | |
| AUX interface cable – Jack 1/4″ | In distribution | |
| Pressure output cable – Schwarzer Cardis | In distribution | |
| AUX interface cable – GE TRAM | In distribution | |
| AUX interface cable – Mennen Model 267 | In distribution | |
| AUX interface cable – Schwarzer Cardis | In distribution | |
| AUX interface cable – Fysicon QMAPP | In distribution | |
| OpM3 Optical Unit | In distribution | |
| Pressure output cable – Claris WorkMate | In distribution | |
| AUX interface cable – GE X5 | In distribution | |
| AUX interface cable – Jack 3.5mm | In distribution | |
| AO cable – GE TRAM 2.9m | In distribution | |
| AUX interface cable – Siemens Sensis | In distribution | |
| AUX interface cable – Siemens Vibe AO2 | In distribution | |
| AO transducer cable – Siemens Sensis | In distribution | |
| Pressure output cable – Nihon Koden | In distribution | |
| OpM3-OU Power Supply Cable | In distribution | |
| AUX interface cable – GE TRAM 450SL | In distribution | |
| AUX interface cable – GE PDM | In distribution | |
| Reference probe 14800nm | In distribution | |
| Pressure output cable – Siemens Sensis | In distribution | |
| AUX interface cable – Siemens Axiom | In distribution | |
| AO cable – GE CLAB II Plus 2.9m | In distribution | |
| OpM3 Display Unit 15″ | In distribution | |
| Pressure output cable – Philips XperFCII | In distribution | |
| OpM3-DU Wireless dongle | In distribution | |
| Pressure output cable – METEK David | In distribution | |
| Reference probe 16500nm | In distribution | |
| Direct AO cable – Utah transducer | In distribution | |
| AO cable – Fukuda Denshi FCL-1000 | In distribution | |
| AUX interface cable – BNC male (Philips) | In distribution | |
| AO cable – QynetiQ | In distribution | |
| Capture Unit Kit | In distribution | |
| AO cable – Mckesson/Merge | In distribution | |
| Pressure output cable – Fysicon QMAPP | In distribution | |
| AO cable – Mennen Model 267 | In distribution | |
| AUX interface cable – Siemens Vibe | In distribution | |
| Pressure output cable – QynetiQ | In distribution | |
| AUX interface cable – GE TRAM D15 S4 WB | In distribution | |
| Power Supply SL Power 12V Opsens | In distribution | |
| AO cable – Siemens Sensis 7pins | In distribution | |
| AO cable – Philips/WITT 2.9m | In distribution | |
| Direct AO cable – Edwards transducer | In distribution | |
| Pressure output cable – GE CLAB II plus | In distribution | |
| OpM3 Handle Unit | In distribution | |
| AUX interface cable – Mennen CFE | In distribution | |
| AO cable – Ortivus Coronet | In distribution | |
| OpM3 OU-DU LAN Cable | In distribution | |
| Pressure output cable – GE TRAM | In distribution | |
| AO cable – METEK David | In distribution | |
| Pressure output cable – Nihon Kohden 15 pins | In distribution | |
| Pressure output cable – Philips XPER | In distribution | |
| AO cable – Philips Xper Flex Cardio 2.9m | In distribution | |
| Reference probe 18500nm | In distribution | |
| Pressure output cable – Mckesson/Merge | In distribution | |
| Pressure output cable – Ortivus CoroNet | In distribution | |
| AO cable – Claris WorkMate | In distribution | |
| AO cable – Fysicon QMAPP | In distribution | |
| Pressure output cable – Bard Clearsign | In distribution | |
| AUX interface cable – D15 GE TRAM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Truwave | Edwards Lifesciences Technology Sarl | 456 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 45 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 24 |
| PX1800 → Truwave Cables | Edwards Lifesciences Technology Sarl | 22 |
| Truwave, Vamp JR | Edwards Lifesciences Technology Sarl | 12 |
| Truwave Cables | Edwards Lifesciences Technology Sarl | 7 |
| TruWave, Vamp Plus | Becton, Dickinson AND Company | 5 |
| TruWave | Becton, Dickinson AND Company | 4 |
| Comet | Boston Scientific Corporation | 4 |
| Medline Industries, Inc. | Medline Industries, Inc. | 4 |
| Pressure Tubing | Edwards Lifesciences Technology Sarl | 3 |
| OptoMonitor | Opsens Inc. | 3 |
Showing 12 of 63. All products under Transducer, Pressure, Catheter Tip
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251367 | 2026-01-16 |
| K241418 | 2025-02-12 |
| K202943 | 2020-11-24 |
| K193620 | 2020-06-18 |
| K192340 | 2019-12-12 |
| K161263 | 2016-09-13 |
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.