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TBS iNsight 4.0

by medimaps group SA

TBS iNsight 4.0 is a Class II device made by medimaps group SA, cleared under FDA 510(k) K243218 on 17 Jan 2025 and listed in FDA GUDID since 13 Feb 2025 (UDI-DI B214OSTBSIV400), 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

510(k) K243218

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 NumberB214OSTBSIV400 UDI-DI Date13 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243218 Date17 Jan 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243218 decided 17 Jan 2025 Active
  • FDA GUDID UDI-DI B214OSTBSIV400 listed 13 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243218
  2. Listed FDA GUDID B214OSTBSIV400

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TBS iNsight
Generic name
Basic x-ray clinical assessment support software
Model / reference
4.0
Primary DI / UDI-DI
B214OSTBSIV400
510(k) Number
FDA product code
KGI
GMDN term
Basic x-ray clinical assessment support software
Device class
Class II
Regulation number
892.1170
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic diagnostic x-ray system application software

Similar devices in this category

Other devices filed under Basic diagnostic x-ray system application software.

Other devices from medimaps group SA

See all devices from medimaps group SA →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)