Illumisite
Bronchoscope Adapter for use with Olympus 190 bronchoscopes
8manufacturers in China registered for this device type
25catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| 510(k) | K191394 |
| Record published | 2021-10-28 |
| Record revised | 2025-06-24 (version 16) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep Dry |
| Packaging | Case of 10 |
| Sizes | Length 1070 mm; outer diameter 2.7 mm; angle 45 to 180 ° |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ILS-0450-KT | Length 1070 mm | In distribution | |
| ILS-1000-CS | Electrical Force,220-240,V; | In distribution | |
| ILS-2000-PK | In distribution | ||
| ILS-1000-CS | In distribution | ||
| ILS-0450-KT | Outer Diameter 2.7 mm | In distribution | |
| ILS-1800-KT | Length 1070 mm | In distribution | |
| ILS-1000-SP | 60 | In distribution | |
| ILS-2300-BA | In distribution | ||
| ILS-1000-CS | Electrical Force,100-120,V; | In distribution | |
| ILS-1000-SP | 60 | In distribution | |
| ILS-2300-PK | In distribution | ||
| ILS-1000-CS | In distribution | ||
| ILS-2200-PK | In distribution | ||
| Procedure Application V1.0 | In distribution | ||
| ILS-2100-BA | In distribution | ||
| ILS-2200-BA | In distribution | ||
| ILS-1000-CS | Electrical Force,220-240,V; | In distribution | |
| ILS-0900-KT | Length 1070 mm | In distribution | |
| Planning Application V1.0 | In distribution | ||
| ILS-2100-PK | In distribution | ||
| ILS-2000-BA | In distribution | ||
| ILS-1000-CS | Electrical Force,220-240,V; | In distribution | |
| ILS-1000-CS | Electrical Force,220-240,V; | In distribution | |
| ILS-1000-CS | Electrical Force,220-240,V; | In distribution | |
| ILS-1000-CS | Electrical Force,100-120,V; | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
| Imactis® | Imactis, SAS | 6 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2023-05-22 | Class II | Process control | Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer. | 1 unit |
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.