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suiteHEART 5

by Neosoft, LLC

Ref NS-02-046-0009

suiteHEART 5 is a device classified as Class IIa in the EU and Class II in the US made by Neosoft, LLC, registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI B-00850001088015), cleared under FDA 510(k) K130228 on 20 Mar 2013 and listed in FDA GUDID since 15 Jul 2019 (UDI-DI 00850001088015), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130228

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850001088015 Basic UDI-DI 00850001088015UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850001088015 UDI-DI Date15 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130228 Date20 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00850001088015 registered 8 Jul 2026 Active
  • FDA 510(k) K130228 decided 20 Mar 2013 Active
  • FDA GUDID UDI-DI 00850001088015 listed 15 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K130228
  2. Listed FDA GUDID 00850001088015
  3. Registered EUDAMED B-00850001088015

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
suiteHEART
Generic name
MRI system application software
Model / reference
NS-02-046-0009 EUDAMED
5 GUDID
Primary DI / UDI-DI
00850001088015
Basic UDI-DI
B-00850001088015
510(k) Number
FDA product code
LLZ
EMDN code
Z11050192 Magnetic resonance (MR) systems - medical device software
GMDN term
MRI system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
NS-02-046-0009
GUDID
5
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: MRI system application software

Similar devices in this category

Other devices filed under MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE.

Other devices from Neosoft, LLC

Properties

  • Prescription use
Other properties (24, all answered No)