RamSoft 6.0.11.11031A

by Ramsoft Inc 3 variants

RamSoft 6.0.11.11031A (PSPACS6) 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 8 May 2024 (UDI-DI B359PSPACS0), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB359PSPACS0 UDI-DI	Date8 May 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK052460	Date21 Sep 2005Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K052460

Across registries

2 registries list this device

FDA 510(k) K052460 decided 21 Sep 2005 Active
FDA GUDID UDI-DI B359PSPACS0 listed 8 May 2024 Listed

Timeline

2 dated events

21 Sep 2005 Cleared FDA 510(k) K052460
8 May 2024 Listed FDA GUDID B359PSPACS0

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: RamSoft
Generic name: Radiology information system
Model / Ref / Catalog: 6.0.11.11031A, PSPACS6

Primary DI / UDI-DI: B359PSPACS0
510(k) Number: K052460
FDA product code: LLZ
GMDN term: Radiology information system

Device class: Class II
Regulation number: 892.2050
GUDID distribution status: In Commercial Distribution

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Properties

Lot / batch number
Manufacturing date

Other properties (13, all answered No)