Profile-ESP Radiographic Marker
The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP…
The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service. The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required. Length → approximately 36” / Weight → approximately 5 oz.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
Record
| Listed by | Ortho Kinematics, Inc., United States |
|---|---|
| FDA product code | JAC |
| Device type | System, X-Ray, Film Marking, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1640 |
| Premarket notification | Exempt |
| Record published | 2019-02-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Suremark | Jessop Precision Products Inc. | 18 |
| N-Spot | Beekley Corporation | 16 |
| PortalMark | Jessop Precision Products Inc. | 14 |
| Xact | Solstice Corporation | 14 |
| TomoSPOT | Beekley Corporation | 10 |
| RT-Spot | Beekley Corporation | 8 |
| O-Spot | Beekley Corporation | 8 |
| MR-Spot | Beekley Corporation | 8 |
| CT-Spot | Beekley Corporation | 8 |
| S-Spot | Beekley Corporation | 8 |
| CT-Markers | Nucletron B.V. | 7 |
| Scaneez | Jessop Precision Products Inc. | 7 |
Showing 12 of 68. All products under System, X-Ray, Film Marking, Radiographic
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.