Flex Focus Ultrasound System
- Primary DI
- 05704916001025
- Brand
- Flex Focus Ultrasound System
- Company
- BK MEDICAL APS
- Model
- 1202
- Device description
- Ultrasound scanner 1202 and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging.Signal analysis and display.Guidance of biopsy needles, geometrical measurements and calculation of parameters.An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.
- Published
- 2016-09-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
Product Codes#
Product Code Classifications#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05704916001025 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05704916001025 | 05704916001025 | 5704916001025 |
GMDN Terms#
| Term | Definition |
|---|---|
| General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +4544528100 | info@bkultrasound.com |
| +4544528100 | info@bkmedical.com |
Regulatory Flags#
- DUNS number
- 310093901
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05704916000684 | Single-Use Biopsy guide | UA1257-S14 | 2016-09-17 | |
| 05704916000707 | Extended, Single-Use Biopsy Guide | UA1257-S17E | 2016-09-17 | |
| 05704916000721 | Single-Use Biplane Biopsy Guide | UA1322-S | 2016-09-17 | |
| 05704916000745 | Single-Use Biplane Biopsy Guide | UA1322-S14 | 2016-09-17 | |
| 05704916000769 | Single-Use Endfire Biopsy Guide | UA1323-S | 2016-09-17 | |
| 05704916000783 | Single-Use Dual Biopsy Guide | UA1329-S | 2016-09-17 | |
| 05704916000806 | Single-Use Needle Guide | UA1335 | 2016-09-17 | |
| 05704916000820 | Single-Use Needle Guide | UA1336 | 2016-09-17 | |
| 05704916000844 | Single-Use Needle Guide | UA1337 | 2016-09-17 | |
| 05704916000868 | Single-Use Needle Guide | UA1338 | 2016-09-17 | |
| 05704916000882 | Single Use Needle Guide | UA1339 | 2016-12-09 | |
| 05704916000967 | Disposable Needle Guide | UA1344 | 2025-04-30 | |
| 05704916000981 | Single-Use Needle Guide | UA1345 | 2016-09-17 | |
| 05704916001001 | Single-Use Needle Guide | UA1346 | 2016-09-17 | |
| 05704916001681 | Non-implantable needle guide, single-use | UA1353-SIP | 2022-12-07 | |
| 05704916000288 | Foot Switch | UA2352 | 2025-05-07 | |
| 05704916000318 | Wireless Remote Control | UA2361 | 2025-05-07 | |
| 05704916001612 | Wireless Remote Control | UA2370 | 2025-05-07 | |
| 05704916001346 | Water Standoff Collar | UA0671 | 2025-04-30 | |
| 05704916001353 | Rectosigmoidoscope with Obturator | UA0672 | 2025-04-30 |
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