Intra.Ox Optical QC Target
Catalogue number OXY2-QCT-1, listed by Vioptix, Inc., United States, under Oximeter, Tissue Saturation. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Sichuan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Vioptix, Inc., United States |
|---|---|
| FDA product code | MUD |
| Device type | Oximeter, Tissue Saturation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Manufacturer |
| 510(k) | K191676 |
| Record published | 2020-04-17 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OXY2-QCT-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invos | Covidien LP | 54 |
| Nonin | Nonin Medical, Inc. | 30 |
| Fore-Sight Elite® | Cas Medical Systems, Inc. | 12 |
| Fore-Sight® | Cas Medical Systems, Inc. | 9 |
| ForeSight | Edwards Lifesciences Technology Sarl | 7 |
| Spectros T-Stat | Spectros Corporation | 7 |
| Component Neuromonitoring System | Moberg Research, Inc. | 6 |
| HyperView | Hypermed Imaging, Inc. | 6 |
| O3 | Masimo Corporation | 5 |
| Mespere | Mespere Lifesciences Inc. | 3 |
| SnapshotNIR | Kent Imaging Inc | 2 |
| Moor Instruments Ltd | Moor Instruments Ltd. | 2 |
Showing 12 of 30. All products under Oximeter, Tissue Saturation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250519 | 2025-06-26 |
| K233488 | 2024-02-28 |
| K221010 | 2022-05-03 |
| K191676 | 2019-09-16 |
| K163472 | 2017-11-16 |
| K133983 | 2014-09-12 |
| K141234 | 2014-07-01 |
| K042657 | 2005-01-10 |
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.