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BoneView 1.1.X

by Gleamer Sas

BoneView 1.1.X is a radiological PACS-dedicated management software (FDA Class II; FDA product code QBS, Radiological Computer Assisted Detection/Diagnosis Software For Fracture) made by Gleamer Sas, cleared under FDA 510(k) K222176 on 2 Mar 2023 and listed in FDA GUDID since 16 Mar 2023 (UDI-DI 03770020839085), 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) K222176

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 Number03770020839085 UDI-DI Date16 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK222176 Date2 Mar 2023IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222176 decided 2 Mar 2023 Active
  • FDA GUDID UDI-DI 03770020839085 listed 16 Mar 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222176
  2. Listed FDA GUDID 03770020839085

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BoneView
Generic name
Radiological PACS-dedicated management software
Model / reference
1.1.X
Primary DI / UDI-DI
03770020839085
510(k) Number
FDA product code
QBS
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2090
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological PACS software

Similar devices in this category

Other devices filed under Radiological PACS software.

Other devices from Gleamer Sas

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Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)