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ImagineMed IM1210

by LifeSignals, Inc.

ImagineMed IM1210 is a Class II device made by LifeSignals, Inc., cleared under FDA 510(k) K172011 on 14 Jun 2018 and listed in FDA GUDID since 19 Oct 2018 (UDI-DI B353IM12101), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K172011

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB353IM12101 UDI-DI Date19 Oct 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172011 Date14 Jun 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172011 decided 14 Jun 2018 Active
  • FDA GUDID UDI-DI B353IM12101 listed 19 Oct 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172011
  2. Listed FDA GUDID B353IM12101

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ImagineMed
Generic name
Electrocardiography telemetric monitoring system
Model / reference
IM1210
Description
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Primary DI / UDI-DI
B353IM12101
510(k) Number
FDA product code
DRG, DRX, DRT
GMDN term
Electrocardiography telemetric monitoring system
Device class
Class II
Regulation number
870.2910, 870.2360, 870.2300
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency).

Other devices from LifeSignals, Inc.

See all devices from LifeSignals, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)