CAAS Workstation 8.0

by Pie Medical Imaging B.V.

CAAS Workstation 8.0 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Pie Medical Imaging B.V., cleared under FDA 510(k) K180019 on 3 May 2018 (1 earlier submission) and listed in FDA GUDID since 28 Nov 2017 (UDI-DI 08056304453761), 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

+1 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK180019	Date3 May 2018Decided	StatusActive
United States	GUDID listing	Number08056304453761 UDI-DI	Date28 Nov 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK151780	Date11 Mar 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08056304453761
FDA 510(k) database 510(k) number K180019
FDA 510(k) database 510(k) number K151780

Across registries

2 registries list this device

FDA 510(k) K180019 decided 3 May 2018 Active· +1 more in the status table
FDA GUDID UDI-DI 08056304453761 listed 28 Nov 2017 Listed

Timeline

3 dated events

11 Mar 2016 Cleared FDA 510(k) K151780
28 Nov 2017 Listed FDA GUDID 08056304453761
3 May 2018 Cleared FDA 510(k) K180019

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CAAS Workstation
Generic name: Radiology DICOM image processing application software
Model / reference: 8.0

Primary DI / UDI-DI: 08056304453761
510(k) Number: K151780
K180019
FDA product code: LLZ
GMDN term: Radiology DICOM image processing application software

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

Similar devices in this category

Other devices filed under Radiology DICOM image processing application software.

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3mensio Workstation 8.1 Open recall

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See all devices from Pie Medical Imaging B.V. →

Properties

Prescription use
Manufacturing date

Other properties (13, all answered No)