510(k) Report

510(k) · Cleared

Cleared

Cerner Provision Workstation

K070394510(k) TraditionalCleared Mar 27, 200746-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cerner Corp. · LLZ System, Image Processing, Radiological

Cleared on Mar 27, 2007 after a 46-day review. The FDA summary names no predicate by number.

Decided
Mar 27, 2007
Review
46 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K070394Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

The CernerProVision Workstation is a software application intended for the rendering, visualization and manipulating of medical images to support the image display needs of clinicians, diagnosticians and technologists. Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review. The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a…

Read the full statement (114 words)

The CernerProVision Workstation is a software application intended for the rendering,

visualization and manipulating of medical images to support the image display needs of

clinicians, diagnosticians and technologists.

Application capabilities enable primary diagnostic review, interpretation and distribution

viewing for physician review.

The Cerner ProVision Workstation can be utilized in a standalone implementation, not

interfaced or integrated to a Radiology Information System, or as component of a unified

RIS/PACS solution.

Lossy compressed mammographic images and digitized film screen images must not be

reviewed for primary image interpretations. Mammographic images may only be

interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and

meets other technical specifications reviewed and accepted by FDA

Indications for use as stated in the FDA summary.

More from Cerner Corp.

7 FDA decisions under this applicant name. See the company

  • K121758Cerner Fetalink+(VERSION1.0)Cerner Corp. · 2012
  • K093134Cerner Careaware IbusCerner Corp. · 2009
  • K091251Cerner Fetalink (Version 1.0)Cerner Corp. · 2009
  • K091032Cerner Provision Workstation (Version 2.5)Cerner Corp. · 2009
  • K000770Proview Medical Image Display ModuleCerner Corp. · 2000

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K070394 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070394: Cerner Provision Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070394

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026