- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Feb 25, 2025
0860000606100001R3Swoop® Portable MR Imaging® System is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Hyperfine, Inc.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
US-MF-000029806(01)00850043319009
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
5 warnings recorded — scroll inside the panel to see all entries.
It is not safe to start using the Swoop system before reading and understanding all the information provided in this IFU.
An Active Implantable Medical Device (AIMD) is a medical device that for relies on electrical energy or other power sources to function and is either partly or totally introduced into the human body. Scanning an AIMD may result in serious patient injury, and/or malfunction of the AIMD. Patients with devices labeled MR Safe are safe in the Swoop system. Patients with devices labeled MR Conditional and MR Unsafe should be further evaluated by the supervising physician to determine whether or not to scan them. This determination should be made based on a careful evaluation of risks versus benefits. Follow your institutions ultra-low-field MRI screening protocols. AIMDs that may be impacted include, but are not limited to: • Cardiac pacemaker • Implantable cardioverter defibrillator (ICD) • Implantable loop recorder or implantable cardiac monitor (ICM) • Left ventricular assist device (LVAD) • Total artificial heart • Implanted insulin pump • Implantable infusion pump • Neuromodulation system including deep brain stimulation (DBS), spinal cord stimulation (SCS), Vagus nerve stimulation (VNS), responsive neurostimulation system (RNS) or other similar device • Cochlear implant and other internal hearing devices • Intracranial pressure monitoring device
Plug the Swoop system into its own dedicated wall AC, grounded power outlet to avoid overloading the circuit and avoid the risk of electrical shock
Prior to use, carefully inspect the Swoop system. Check the housing, head RF coil, cables, and connections for signs of damage such as cracks, chips, abrasions, or other noticeable problems. Using damaged equipment or accessories may cause the Swoop system to perform improperly and/or risk electrical hazard or may result in injury to the patient or the Swoop system operator. Refer servicing to qualified service personnel only.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Italy; available across 9 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jan 8, 2025 | Still on market |
| Germany | Jan 8, 2025 | Still on market |
| Spain | Jan 8, 2025 | Still on market |
| France | Jan 8, 2025 | Still on market |
| Norway | Jan 1, 2026 | Still on market |
| Poland | Dec 1, 2025 | Still on market |
| Romania | Mar 25, 2025 | Still on market |
| Sweden | Dec 26, 2025 | Still on market |
| Türkiye | Dec 1, 2025 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00850043319009Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
0860000606100001R3900-11001-06 UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11050104CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2TPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.0860000606100001R3On the marketSwoop Transmit and Receive Radio Frequency Head Coil0860000606100001R3On the marketSwoop Transmit and Receive Radio Frequency Head Coil0860000606100001R3On the market810-11113-00 0860000606100002R5On the market810-11049-010860000606100003R7On the market900-11021-000850043319900110210026On the marketNo certificate specifically references this device's Basic UDI-DI.