MAC
The FDA filing identifies the MAC VU360 Resting ECG Analysis System, including the listed VU360 model. It describes a mobile electrocardiograph that acquires, analyzes, displays, and…
The FDA filing identifies the MAC VU360 Resting ECG Analysis System, including the listed VU360 model. It describes a mobile electrocardiograph that acquires, analyzes, displays, and records signals from surface ECG electrodes.
The filing says the system can capture 3, 6, 12, or 15 lead ECGs, provide interpretive analysis, and print reports. The indications include acquiring, analyzing, displaying, and printing electrocardiograms, with interpretation provided for physician consideration.
Listed Item
MAC VU360 V3.00 SW Upgrade
Data Handling
After acquisition, the filing says ECG data can be analyzed, reviewed, stored, printed, or transmitted. The device is intended to be used under direct supervision of a licensed healthcare practitioner by trained operators in a hospital or professional facility.
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (2), Beijing (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Showing 12 of 18. All 18 manufacturers in China registered for Electrocardiograph
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K173830 |
| Record published | 2018-10-02 |
| Record revised | 2025-04-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 20 to 95 % RH; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 15 to 95 % RH |
| Distribution end date | 2019-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VU360 | In distribution | |
| 600 | In distribution | |
| 7 | In distribution | |
| 7 | In distribution | |
| VU | In distribution | |
| 5500 HD | In distribution | |
| 800 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,734 |
| M Series Biphasic | Zoll Medical Corporation | 93 |
| ELI 380 | Mortara Instrument, Inc. | 69 |
| Patient Cable Lead Set | Mortara Instrument, Inc. | 56 |
| ELI 250c | Mortara Instrument, Inc. | 50 |
| Lutech | Lutech Industries | 49 |
| ELI 150c | Mortara Instrument, Inc. | 47 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 41 |
| ELI 280 | Mortara Instrument, Inc. | 41 |
| Electrocardiograph | Edan Instruments, Inc. | 38 |
| Q-Stress | Mortara Instrument, Inc. | 25 |
| XScribe | Mortara Instrument, Inc. | 22 |
Showing 12 of 177. All products under Electrocardiograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251670 | 2026-01-26 |
| K221321 | 2022-10-18 |
| K203786 | 2021-04-30 |
| K173830 | 2018-09-18 |
| K120770 | 2012-12-06 |
| K103765 | 2011-05-17 |
| K110266 | 2011-04-29 |
| K081437 | 2008-07-15 |
| K073625 | 2008-01-25 |
| K042177 | 2004-08-27 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems Information Technologies, Inc. | 510(k) number | 2026-06-29 | Class II | Software design | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may re | 163 units | |
| GE Medical Systems, LLC | 510(k) number | 2025-08-22 | Class II | Device Design | If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisiti | 29,225 units | |
| GE Medical Systems, LLC | 510(k) number | 2020-10-27 | Class II | Use error | Incorrect patient identification and/or patient demographic errors. | 5,284 units | 2024-05-03 |
| GE Medical Systems, LLC | 510(k) number | 2019-06-28 | Class II | Software design | Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The | 369 units | 2021-04-13 |
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.