A.M.I. HAL-II Electronic System
- Primary DI
- EAMIAHE2030
- Brand
- A.M.I. HAL-II Electronic System
- Company
- AMI Agency for Medical Innovations GmbH
- Model
- AHE 203
- Catalog number
- AHE 203
- Device description
- Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the A.M.I. HAL/RAR System.The A.M.I. HAL-II Electronic System is a Doppler-based device. It is powered by a DC voltage source (rechargeable batteries or 12 V adapter). The A.M.I. HAL-II Electronic System generates electrical signals, calculates differences between the wavelength of outgoing and reflected electrical signals, and generates an acoustic Doppler signal.Together with auxiliary A.M.I. devices (A.M.I. HAL Handle, Probe and Sleeve) the A.M.I. HAL-II Electronic System serves for the detection of haemorrhoidal arteries and enables manual ligation of detected arteries, as well as mucopexy of prolapsing haemorrhoidal mucosa.
- Published
- 2018-11-28
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K061831 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| EAMIAHE2030 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Noninvasive vascular ultrasound system, battery-powered | A hand-held, battery-powered device assembly consisting of a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis, and the vascular states of partially severed extremities), ankle pressure index, and/or blood flow wave form recording. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Depth | 260 | Millimeter |
| Height | 140 | Millimeter |
| Weight | 3.2 | Kilogram |
| Width | 385 | Millimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Handling Environment Humidity | 30 Percent (%) Relative Humidity | 75 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius | |
| Storage Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 75 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -20 Degrees Celsius | 60 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 303655286
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| EAMIRAR20810 | RAR Flexi Probe | RAR2081 | RAR2081 | 2018-11-28 |
| EAMIICT50100 | i-Cut Power Supply | ICT5010 | 2025-05-05 | |
| EAMIICT50110 | i-Cut | ICT5011 | ICT5011 | 2025-05-05 |
| EAMIICT50500 | i-Cut Power Supply Type A | ICT5050 | 2025-05-05 | |
| EAMIECI10310 | A.M.I. EasyClinch Disposable Tips Premium | ECI1031 | ECI1031 | 2019-04-05 |
| EAMIECM10110 | EasyClinch micro | ECM1011 | ECM1011 | 2019-04-05 |
| EAMIEDI10310 | A.M.I. EasyDissect Disposable Tips Premium | EDI1031 | EDI1031 | 2019-04-05 |
| EAMIEDI10510 | A.M.I. EasyHook | EDI1051 | EDI1051 | 2019-04-05 |
| EAMIEDM10110 | EasyDissect micro | EDM1011 | EDM1011 | 2019-04-05 |
| EAMIESI11310 | A.M.I. EasyShear Disposable Tips Premium | ESI1131 | ESI1131 | 2019-04-05 |
| EAMIESI11510 | A.M.I. EasyShear Mini Disposable Tips Premium | ESI1151 | ESI1151 | 2019-04-05 |
| EAMIESI12100 | Soft Inserts | ESI1210 | ESI1210 | 2019-04-05 |
| EAMIESM10110 | EasyShears micro | ESM1011 | ESM1011 | 2019-04-05 |
| EAMIEVI10110 | Viper | EVI1011 | EVI1011 | 2019-04-05 |
| EAMIEAH10100 | EasyAct Handle | EAH1010 | EAH1010 | 2019-04-05 |
| EAMIEAS13100 | EasyAct 3 S | EAS1310 | EAS1310 | 2019-04-05 |
| EAMIEAS13200 | EasyAct 3 M | EAS1320 | EAS1320 | 2019-04-05 |
| EAMIEAS15100 | EasyAct 5 S | EAS1510 | EAS1510 | 2019-04-05 |
| EAMIEAS15200 | EasyAct 5 M | EAS1520 | EAS1520 | 2019-04-05 |
| EAMIEAS15300 | EasyAct 5 L | EAS1530 | EAS1530 | 2019-04-05 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06903053124348 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124355 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124379 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124430 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124461 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124492 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124546 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124560 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124591 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124607 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124614 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124683 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124706 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124720 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124775 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 06903053124829 | Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 2026-06-03 |
| 00850050934240 | EndoSound® EVS SideBeam 5103 | Endosound, Inc. | IYN | 2026-06-01 |
| 00850050934257 | EndoSound® Coax Transducer Extension Connector (TEC) | Endosound, Inc. | IYN | 2026-06-01 |
| 00850050934264 | EndoSound® EVS SideBeam 5105 (4 pouches) | Endosound, Inc. | IYN | 2026-06-01 |
| 04987670105937 | DIAGNOSTIC ULTRASOUND SYSTEM | CANON INC. | IYN | 2026-06-01 |
| 04987670106194 | DIAGNOSTIC ULTRASOUND SYSTEM | CANON INC. | IYN | 2026-06-01 |
| 08800013510112 | L8-17H | Alpinion Medical Systems Co., Ltd. | IYN | 2026-05-29 |
| 00198953121382 | Voluson | GE Ultrasound Korea Ltd. | IYN | 2026-05-28 |
| 08800290066784 | EVO Q10 Diagnostic Ultrasound System | SAMSUNG MEDISON CO., LTD. | IYN | 2026-04-03 |
| 08800340506147 | EVO QH10 Diagnostic Ultrasound System | SAMSUNG MEDISON CO., LTD. | IYN | 2026-04-03 |
| 08800340509988 | EVO XQ10 Diagnostic Ultrasound System | SAMSUNG MEDISON CO., LTD. | IYN | 2026-04-03 |
| 08800290041934 | LA2-9S | SAMSUNG MEDISON CO., LTD. | IYN | 2025-12-05 |
| 08800290042665 | CA3-10A | SAMSUNG MEDISON CO., LTD. | IYN | 2025-12-05 |
| 08800290041699 | L3-22 | SAMSUNG MEDISON CO., LTD. | IYN | 2025-10-13 |
| 08800290042122 | LA2-16S | SAMSUNG MEDISON CO., LTD. | IYN | 2025-10-13 |