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Mim 6.7

by Mim Software Inc.

Mim 6.7, a radiological PACS-dedicated management software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Mim Software Inc., was cleared under FDA 510(k) K151913 on 25 Apr 2016 and listed in FDA GUDID on 21 Mar 2017 (UDI-DI 00865936000230); the registry lists it as not in commercial distribution (GUDID) as of 22 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 22 Oct 2026

Documents

510(k) K151913

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 Number00865936000230 UDI-DI Date21 Mar 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151913 Date25 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151913 decided 25 Apr 2016 Active
  • FDA GUDID UDI-DI 00865936000230 listed 21 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151913
  2. Listed FDA GUDID 00865936000230

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mim
Generic name
Radiological PACS-dedicated management software
Model / reference
6.7
Primary DI / UDI-DI
00865936000230
510(k) Number
FDA product code
LLZ
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Similar devices

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

Other devices from Mim Software Inc.

See all devices from Mim Software Inc. →

Properties

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