510(k) · Cleared

Cleared

PROView

K193306510(k) TraditionalCleared Nov 17, 2020354-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

GE Medical Systems SCS · LLZ System, Image Processing, Radiological

Cleared on Nov 17, 2020 as substantially equivalent to K192200 (Invivo Corporation, 2019) after a 354-day review. Its family tree reaches back 2 generations to 2012.

Decided: Nov 17, 2020
Review: 354 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K121517 (2012). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK121517 Versavue Enterprise SuiteIcad, Inc. · 2012 · Recalled
1 generation backK192200 DynaCADInvivo Corporation · 2019
This deviceK193306 PROViewGE Medical Systems SCS · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K121517	Versavue Enterprise Suite	Icad, Inc.	2012	1
−1	K192200	DynaCAD	Invivo Corporation	2019	—
0 (this device)	K193306	PROView	GE Medical Systems SCS	2020	—

FIG. 1 — Lineage of K193306, 2012–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K192200	DynaCAD Summary page 5 …ealthcare 510(k) Premarket Notification Submission Predicate Device: Device Name: DynaCAD 510(k) number: K192200 cleared on Oct 9, 2019 Regulation number/ 21 CFR 892.2050 Picture archiving and communication system / Product Code:…	Invivo Corporation	2019	—

Also cleared against K192200: 2 other devices →

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.

What does this lineage say?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K192200.

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. 2020, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

PROView is an aiding tool for the clinicians to review multi-parametric prostate magnetic resonance (MR) images following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians. It is…

Read the full statement (100 words)

It is intended for use by professionals, such as clinicians, radiologists, or physicians. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of prostate images or quantitative data.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K193306 · printed Nov 4, 2026

Cite this page

510(k) Report. “K193306: PROView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193306

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026