Dunlee Sentinelle
VT 1.5T8Ch TT Titan Full Set w Grid: 1 Vanguard Atlas/Titan; 1 BOX of 10 BIOPSY GRID, STERILIZED; 1 INTERFACE BOX 1.5T VT ATLAS; 1 COIL 8CH MEDIAL ARRAY VT 1.5T; 1 COIL LAT 8CH ARRAY LEFT…
VT 1.5T8Ch TT Titan Full Set w Grid: 1 Vanguard Atlas/Titan; 1 BOX of 10 BIOPSY GRID, STERILIZED; 1 INTERFACE BOX 1.5T VT ATLAS; 1 COIL 8CH MEDIAL ARRAY VT 1.5T; 1 COIL LAT 8CH ARRAY LEFT VT 1.5T; 1 COIL LAT 8CH ARRAY RIGHT VT 1.5T; 1 COIL SINGLE LOOP LEFT VT 1.5T 8CH; 1 COIL SINGLE LOOP RIGHT VT 1.5T 8CH; 1 COIL MEDIAL PLUG VT 1.5T.
9manufacturers in China registered for this device type
192catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (2), Tianjin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | Tianjin | Specification developer | 3 |
| Shenzhen RF Tech Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 2 |
| Shanghai Chenguang Medical Technologies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| Shanghai Chenshi Medical Instruments Co., Ltd. | Shanghai | Shanghai | Exporter | 2 |
Record
| Listed by | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K112112 |
| Record published | 2022-06-09 |
| Record revised | 2025-09-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature -30 to 65 °C; Handling environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Lateral Single Loop Coil Right VGTT | In distribution | |
| Medial Plug VG GE450 | In distribution | |
| HD T/R QUAD EXTREMITY COIL | In distribution | |
| INTERFACE BOX BREAST COIL 3T | In distribution | |
| 989603218241 | In distribution | |
| Lateral Single Loop Coil Left VGTT | In distribution | |
| 8Ch Medial Coil Sen 1.5T | In distribution | |
| 16Ch Interface Box Breast Coil Sen 3T | In distribution | |
| Interface Box VT | In distribution | |
| 3Ch Left Coil Element Sen 3T | In distribution | |
| Medial Coil Element Sen 1.5T | In distribution | |
| Lateral Single Loop Coil Left VG STR | In distribution | |
| 989603218331 | In distribution | |
| 3.0T HD T/R Quad Extremity Coil (flat base) | In distribution | |
| Lateral Single Loop Coil Left VG GE450 | In distribution | |
| Vanguard for Siemens Breast MRI Auxiliary Table | In distribution | |
| 3Ch Left Coil Element Sen 1.5T | In distribution | |
| 16Ch Interface Box Breast Coil Sen 1.5T | In distribution | |
| Lateral Array Coil Right VG GE450 | In distribution | |
| 1.5T 32Ch Cardiac Coil – Anterior | In distribution | |
| 4Ch Left Lateral Coil Sen 1.5 T | In distribution | |
| Medial Array Coil VGTT | In distribution | |
| Medial Plug VG STR | In distribution | |
| Lateral Array Coil Left VG GE750 | In distribution | |
| Interface Box VT | In distribution | |
| 3.0T HD T/R Knee Coil (flat base) | In distribution | |
| 3.0T 32Ch Cardiac Coil – Anterior | In distribution | |
| 989603217861 | In distribution | |
| Lateral Single Loop Coil Right VG GE450 | In distribution | |
| Cable Tray HYP VG STR | In distribution | |
| 1.5T HD T/R QUAD EXTREMITY COIL (flat base) | In distribution | |
| Medial Array Coil VG GE450 | In distribution | |
| Vanguard Breast MRI Table | In distribution | |
| Medial Plug VT | In distribution | |
| Medial Plug Sen 1.5T | In distribution | |
| 989603218261 | In distribution | |
| Medial Coil Element Sen 3T | In distribution | |
| Interface Box VS 16Ch | In distribution | |
| Medial Array Coil VG STR | In distribution | |
| Lateral Array Coil Left VGTT | In distribution | |
| Medial Plug Sen 1.5T | In distribution | |
| Medial Plug VT | In distribution | |
| Vanguard Atlas/Titan | In distribution | |
| 3T HD T/R KNEE ARRAY | In distribution | |
| 1Ch Right Coil Element Sen 3T | In distribution | |
| Lateral Array Coil Right VT | In distribution | |
| 3Ch Left Coil Element Sen 3T | In distribution | |
| Medial Plug VGTT | In distribution | |
| Interface Box Breast Coil Sen 1.5T | In distribution | |
| Lateral Array Coil Left VT | In distribution | |
| Lateral Single Loop Coil Right VG GE750 | In distribution | |
| 4Ch Right Lateral Coil Sen 3T | In distribution | |
| Lateral Array Coil Right VG GE750 | In distribution | |
| Lateral Single Loop Coil Left VGTT | In distribution | |
| Medial Plug VG STR | In distribution | |
| Interface Box VG GE750 | In distribution | |
| Medial Single Loop Coil Left VG STR | In distribution | |
| Medial Array Coil VGTT | In distribution | |
| 16Ch Shoulder Coil | In distribution | |
| Single Loop Coil Right VT | In distribution | |
| 1Ch Right Coil Element Sen 1.5T | In distribution | |
| Lateral Array Coil Right VGTT | In distribution | |
| Single Loop Coil Left VT | In distribution | |
| Lateral Single Loop Coil Left VG GE750 | In distribution | |
| Lateral Array Coil Left VG GE450 | In distribution | |
| 989603217291 | In distribution | |
| Interface Box VGTT 8Ch | In distribution | |
| Interface Box VT | In distribution | |
| Lateral Array Coil Left VT | In distribution | |
| HD T/R QUAD EXTREMITY COIL | In distribution | |
| Medial Plug VGTT | In distribution | |
| Single Loop Coil Left VT | In distribution | |
| Vanguard Atlas/Titan | In distribution | |
| Interface Box VT | In distribution | |
| 989603217321 | In distribution | |
| Vanguard Breast MRI Tabletop Coil | In distribution | |
| 989603218311 | In distribution | |
| Medial Single Loop Coil Right VG STR | In distribution | |
| HD 8Ch Wrist Array | In distribution | |
| Medial Plug VG GE450 | In distribution | |
| 989603217251 | In distribution | |
| Medial Plug VG GE750 | In distribution | |
| Medial Array Coil VT | In distribution | |
| Single Loop Coil Left VT | In distribution | |
| Interface Box VG GE750 | In distribution | |
| Lateral Single Loop Coil Left VG GE750 | In distribution | |
| Medial Plug VGTT | In distribution | |
| Lateral Array Coil Right VG STR | In distribution | |
| 9896-032-17241 | In distribution | |
| Lateral Array Coil Left VG GE750 | In distribution | |
| 1Ch Left Coil Element Sen 1.5T | In distribution | |
| 989603217131 | In distribution | |
| Medial Array Coil VT | In distribution | |
| 8Ch Medial Coil Sen 1.5T | In distribution | |
| 989603217111 | In distribution | |
| Single Loop Coil Right VT | In distribution | |
| Medial Plug Sen 3T VS | In distribution | |
| Lateral Array Coil Right VGTT | In distribution | |
| Lateral Array Coil Left VG STR | In distribution | |
| Lateral Array Coil Left VT | In distribution | |
| Lateral Single Loop Coil Right VG STR | In distribution | |
| COIL SINGLE LOOP RIGHT VT | In distribution | |
| Medial Array Coil VG STR | In distribution | |
| Lateral Array Coil Right VT | In distribution | |
| 8Ch Medial Coil Sen 3T | In distribution | |
| 989603217571 | In distribution | |
| Interface Box VT | In distribution | |
| Vanguard Breast MRI Tabletop Coil | In distribution | |
| 1.5T HD T/R KNEE ARRAY | In distribution | |
| HD 8Ch Wrist Array | In distribution | |
| Single Loop Coil Left VT | In distribution | |
| 989603217231 | In distribution | |
| 4Ch Right Lateral Coil Sen 1.5T | In distribution | |
| 3Ch Right Coil Element Sen 3T | In distribution | |
| 989603217881 | In distribution | |
| 989603217101 | In distribution | |
| 16Ch Interface Box Breast Coil Sen 3T | In distribution | |
| Medial Array Coil VG GE450 | In distribution | |
| Medial Plug VT | In distribution | |
| 989603218221 | In distribution | |
| Lateral Single Loop Coil Left VG GE450 | In distribution | |
| 3Ch Right Coil Element Sen 3T | In distribution | |
| Lateral Single Loop Coil Right VGTT | In distribution | |
| 4Ch Left Lateral Coil Sen 3T | In distribution | |
| Lateral Array Coil Left VG STR | In distribution | |
| 4Ch Right Lateral Coil Sen 1.5T | In distribution | |
| Lateral Single Loop Coil Right VG GE750 | In distribution | |
| 989603217261 | In distribution | |
| 3Ch Right Coil Element Sen 1.5T | In distribution | |
| 4Ch Left Lateral Coil Sen 1.5T | In distribution | |
| 16Ch Shoulder Coil | In distribution | |
| Medial Plug VT | In distribution | |
| Medial Plug Sen 3T | In distribution | |
| Lateral Array Coil Left VGTT | In distribution | |
| Medial Single Loop Coil Right VG STR | In distribution | |
| 989603216931 | In distribution | |
| Interface Box Breast Coil 3T | In distribution | |
| 989603217831 | In distribution | |
| Vanguard Breast MRI Table | In distribution | |
| 989603217281 | In distribution | |
| Lateral Array Coil Left VG GE450 | In distribution | |
| Cable Tray VG GE450 | In distribution | |
| HD 8CH Wrist Array | In distribution | |
| Medial Array Coil VG GE750 | In distribution | |
| Lateral Array Coil Right VT | In distribution | |
| Cable Tray HYP VG STR | In distribution | |
| 1.5T HD T/R Knee Coil (flat base) | In distribution | |
| 1Ch Left Coil Element Sen 3T | In distribution | |
| 1Ch Right Coil Element Sen 1.5T | In distribution | |
| Lateral Array Coil Left VT | In distribution | |
| 3Ch Left Coil Element Sen 1.5T | In distribution | |
| HD 8Ch WRIST ARRAY (Receive Only) | In distribution | |
| HD 8Ch Foot Ankle Coil | In distribution | |
| Interface Box Breast Coil 1.5T | In distribution | |
| 4Ch Left Lateral Coil Sen 3T | In distribution | |
| Lateral Single Loop Coil Left VG STR | In distribution | |
| Vanguard Atlas/Titan | In distribution | |
| Vanguard Breast MRI Table | In distribution | |
| Lateral Array Coil Right VG GE750 | In distribution | |
| Medial Single Loop Coil Left VG STR | In distribution | |
| Medial Array Coil VGTT | In distribution | |
| Interface Box VGTT 8Ch | In distribution | |
| Lateral Single Loop Coil Right VG STR | In distribution | |
| Medial Array Coil VG GE750 | In distribution | |
| 1Ch Left Coil Element Sen 3T | In distribution | |
| 989603217871 | In distribution | |
| 989603217851 | In distribution | |
| 989603217311 | In distribution | |
| 989603217121 | In distribution | |
| 4Ch Right Lateral Coil Sen 3T | In distribution | |
| Patient Support Breast Sen | In distribution | |
| 3Ch Right Coil Element Sen 1.5T | In distribution | |
| 1Ch Right Coil Element Sen 3T | In distribution | |
| Vanguard Breast MRI Table | In distribution | |
| Medial Coil Element Sen 3T | In distribution | |
| Medial Plug VG GE750 | In distribution | |
| Interface Box VT | In distribution | |
| Lateral Array Coil Right VG STR | In distribution | |
| 8Ch Medial Coil Sen 3T | In distribution | |
| 989603217341 | In distribution | |
| Medial Array Coil VT | In distribution | |
| Lateral Array Coil Right VT | In distribution | |
| Single Loop Coil Right VT | In distribution | |
| 989603217331 | In distribution | |
| Lateral Single Loop Coil Right VG GE450 | In distribution | |
| 989603217841 | In distribution | |
| Medial Coil Element Sen 1.5T | In distribution | |
| Cable Tray VG GE450 | In distribution | |
| 989603218271 | In distribution | |
| 989603217301 | In distribution | |
| 1Ch Left Coil Element Sen 1.5T | In distribution | |
| 989603217271 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invivo | Philips DS North America LLC | 185 |
| Philips | Philips DS North America LLC | 88 |
| Coil, Magnetic Resonance, Specialty | Usa Instruments, Inc. | 50 |
| Philips | Shanghai Chenguang Medical Technologies Co., Ltd. | 50 |
| GE | Philips DS North America LLC | 41 |
| MR Coils | Philips Medical Systems Nederland B.V. | 37 |
| MRI Coils | Philips DS North America LLC | 24 |
| DuoFLEX® Coil Suite | M R Instruments, Inc. | 20 |
| RFT | Shenzhen RF Tech Co., Ltd. | 18 |
| AtamA™ System | Monteris Medical Corp | 17 |
| Philips Sentinelle | Philips Medical Systems Nederland B.V. | 16 |
| Dunlee | Philips Medical Systems Nederland B.V. | 16 |
Showing 12 of 713. All products under Coil, Magnetic Resonance, Specialty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262330 | 2026-07-30 |
| K262294 | 2026-07-24 |
| K254190 | 2026-01-14 |
| K243033 | 2024-10-18 |
| K242879 | 2024-10-18 |
| K242096 | 2024-08-12 |
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.