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7290019402558 4000 Type 1.1

by Insightec Ltd

Ref Exablate 4000 Type 1.1 PrimeModel 4000

7290019402558 4000 Type 1.1 (SYS004000-CA) is a device classified as Class IIb in the EU and Class III in the US made by Insightec Ltd, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI 7290015461Ex4000-SYSFB) with CE/MDR certificate 3902589CE01 valid until 1 Feb 2031, approved under FDA PMA P150038 on 11 Jul 2016 and listed in FDA GUDID since 1 Jan 2025 (UDI-DI 07290019402558), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

1 Feb 2031

CE MDR certificate

FDA recalls

None found

in data synced 12 Nov 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

PMA P150038

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290015461Ex4000-SYSFB Basic UDI-DI 07290019402558UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290019402558 UDI-DI Date1 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP150038 Date11 Jul 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7290015461Ex4000-SYSFB registered 4 Aug 2026 Active· +1 more in the status table
  • FDA PMA P150038 decided 11 Jul 2016 Active
  • FDA GUDID UDI-DI 07290019402558 listed 1 Jan 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3902589CE01 Active Reissued

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Feb 2026
    Expires
    1 Feb 2031

Timeline

5 dated events

  1. Approved FDA PMA P150038
  2. Listed FDA GUDID 07290019402558
  3. Certificate issued EUDAMED 3902589CE01
  4. Registered EUDAMED 7290015461Ex4000-SYSFB
  5. Certificate expires EUDAMED 3902589CE01

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Exablate 4000 Prime EUDAMED
7290019402558 GUDID
Generic name
Ultrasonic hyperthermia system
Device name
Exablate 4000
Model / Ref / Catalog
4000 EUDAMED
Exablate 4000 Type 1.1 Prime EUDAMED
4000 Type 1.1 GUDID
SYS004000-CA GUDID
Primary DI / UDI-DI
07290019402558
Basic UDI-DI
7290015461Ex4000-SYSFB
PMA number
FDA product code
POH
EMDN code
Z120610 Ultrasound therapy equipment
GMDN term
Ultrasonic hyperthermia system
Device class
Class IIb EUDAMED
Class III GUDID
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
4000
Exablate 4000 Type 1.1 Prime
GUDID
4000 Type 1.1
Device classEUDAMED
Class IIb
GUDID
Class III

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ultrasonic hyperthermia system

Cleared under the same submission (P150038)

Similar devices in this category

Other devices filed under ULTRASOUND THERAPY EQUIPMENT.

Other devices from Insightec Ltd

See all devices from Insightec Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)