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Joints 4.37

by Medstrat, Inc.

Joints 4.37 is a Class II device made by Medstrat, Inc., cleared under FDA 510(k) K051745 on 14 Jul 2005 and listed in FDA GUDID since 12 Oct 2018 (UDI-DI 00817886020127), active as of 22 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 22 Oct 2026

Documents

510(k) K051745

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817886020127 UDI-DI Date12 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK051745 Date14 Jul 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K051745 decided 14 Jul 2005 Active
  • FDA GUDID UDI-DI 00817886020127 listed 12 Oct 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K051745
  2. Listed FDA GUDID 00817886020127

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Joints
Generic name
Radiology picture archiving and communication system digital archive device
Model / reference
4.37
Primary DI / UDI-DI
00817886020127
510(k) Number
FDA product code
LLZ
GMDN term
Radiology picture archiving and communication system digital archive device
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological PACS softwareRadiology picture archiving and communication system digital archive device

Cleared under the same submission (K051745)

and 8 more cleared under K051745

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Medstrat, Inc.

  • Joints 6.12

    Class II

  • Joints 5.32

    Class II

  • Joints 5.6

    Class II

  • Joints 5.19

    Class II

See all devices from Medstrat, Inc. →

Properties

  • Lot / batch number
Other properties (14, all answered No)