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RamSoft 6.7.0.49

by Ramsoft Inc 3 variants

RamSoft 6.7.0.49 is a Class II device made by Ramsoft Inc, cleared under FDA 510(k) K052460 on 21 Sep 2005 and listed in FDA GUDID since 30 Jan 2026 (UDI-DI B359PSGWY670), 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) K052460

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 NumberB359PSGWY670 UDI-DI Date30 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052460 Date21 Sep 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052460 decided 21 Sep 2005 Active
  • FDA GUDID UDI-DI B359PSGWY670 listed 30 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052460
  2. Listed FDA GUDID B359PSGWY670

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RamSoft
Generic name
Radiological PACS-dedicated management software
Model / reference
6.7.0.49
Primary DI / UDI-DI
B359PSGWY670
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
In Commercial Distribution

Related devices

Cleared under the same submission (K052460)

and 8 more cleared under K052460

Other devices from Ramsoft Inc

See all devices from Ramsoft Inc →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)