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SyMRI 11

by SyntheticMR AB (publ)

SyMRI 11 is a Class II device made by SyntheticMR AB (publ), cleared under FDA 510(k) K201616 on 28 Jul 2020 (3 earlier submissions) and listed in FDA GUDID since 20 Jun 2018 (UDI-DI 07340024700030), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) from GUDID NumberK201616 Date28 Jul 2020IssuedStatusActive
United StatesGUDID listing Number07340024700030 UDI-DI Date20 Jun 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201616 decided 28 Jul 2020 Active· +3 more in the status table
  • FDA GUDID UDI-DI 07340024700030 listed 20 Jun 2018 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K173558
  2. Cleared FDA 510(k) K181093
  3. Listed FDA GUDID 07340024700030
  4. Cleared FDA 510(k) K191036
  5. Cleared FDA 510(k) K201616

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SyMRI
Generic name
MRI system application software
Model / reference
11
Primary DI / UDI-DI
07340024700030
510(k) Number
FDA product code
LNH
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.1000
GUDID distribution status
In Commercial Distribution

Related devices

Category: MRI system application software

Similar devices in this category

Other devices filed under MRI system application software.

Other devices from SyntheticMR AB (publ)

  • SyMRI 14

    Class II

  • SyMRI 10

    Class II

Properties

  • Serial number
Other properties (14, all answered No)