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Modus Plan

by Synaptive Medical Inc.

Ref SYN-0866

Modus Plan (SYN-0866) is a device classified as Class IIa in the EU and Class II in the US made by Synaptive Medical Inc, registered in EUDAMED on 11 Apr 2025 (Basic UDI-DI 67008200002LK), cleared under FDA 510(k) K180394 on 9 Mar 2018 and listed in FDA GUDID since 17 Jan 2025 (UDI-DI 00670082000610), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180394

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number67008200002LK Basic UDI-DI 00670082000610UDI-DIDate11 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00670082000610 UDI-DI Date17 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180394 Date9 Mar 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 67008200002LK registered 11 Apr 2025 Active
  • FDA 510(k) K180394 decided 9 Mar 2018 Active
  • FDA GUDID UDI-DI 00670082000610 listed 17 Jan 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180394
  2. Listed FDA GUDID 00670082000610
  3. Registered EUDAMED 67008200002LK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Radiological PACS-dedicated management software
Model / Ref / Catalog
SYN-0866, 2.2
Primary DI / UDI-DI
00670082000610
Basic UDI-DI
67008200002LK
510(k) Number
FDA product code
LLZ
EMDN code
Z110603 Picture archiving and communication systems
GMDN term
Radiological PACS-dedicated management software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SYN-0866
GUDID
2.2
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.

Manufacturer details

EUDAMED SRN
CA-MF-000010705
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from Synaptive Medical Inc

See all devices from Synaptive Medical Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)