510(k) · Cleared

Cleared

IN-Vision Imaging System

K031148510(k) SpecialCleared May 28, 200348-day reviewClass II21 CFR 870.2330

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

Cleared on May 28, 2003 as substantially equivalent to K944004 (Endosonics Corp., 1995) and 2 other predicates after a 48-day review. Its family tree reaches back 1 generation to 1995. 6 of the 652 devices in its family, counting itself, have a Class I recall. 648 later devices descend from it.

Decided: May 28, 2003
Review: 48 days
Class: Class II
Product code: DXK
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K944004 (1995). 3 ancestors in all. 648 later devices descend from it, 6 citing it directly. 6 of the 652 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK944004 Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)Endosonics Corp. · 1995
This deviceK031148 IN-Vision Imaging SystemJomed, Inc. · 2003
Descendant · cites it directly · 614 of its ownK051920 Volcano S5 Imaging System, Model 804200-001Volcano Corporation · 2005 · Recalled
Descendant · cites it directly · 613 of its ownK061215 Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006
Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Descendant · 4 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled

Showing 5 of 648 descendants. See all descendants

Descendants cleared per year

2005high 53 (2020) · low 0 (2007)2026

Class I recalls in this family

K172258 Novasight Hybrid System2 generations on · 2018
K190106 Intra-Operative Positioning System; Simple Curve…5 generations on · 2019
K242133 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
K241243 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024

Most influential descendants

Showing 5 of 648 · See all

K051920Volcano S5 Imaging System, Model 804200-001Volcano Corporation · 2005 · cites it directly614descendants
K061215Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006 · cites it directly613descendants
K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
K110943Logiq E9GE Healthcare · 2011 · 4 generations on472descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944004	Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)	Endosonics Corp.	1995	—
0 (this device)	K031148	IN-Vision Imaging System	Jomed, Inc.	2003	—
+1	K051920	Volcano S5 Imaging System, Model 804200-001	Volcano Corporation	2005	1
+1	K061215	Volcano S51 Family of Imaging Systems	Volcano Corporation	2006	—
+2	K083095	Sonixtouch Ultrasound System	Ultrasonix Medical Corporation	2008	—
+3	K092271	GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	GE Healthcare	2009	1
+4	K110943	Logiq E9	GE Healthcare	2011	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	2	0
2008	4	0
2009	6	0
2010	5	0
2011	12	0
2012	26	0
2013	23	0
2014	38	0
2015	33	0
2016	38	0
2017	52	0
2018	51	1
2019	41	1
2020	53	0
2021	40	0
2022	44	0
2023	42	1
2024	49	2
2025	52	1
2026	35	0

FIG. 1 — Lineage of K031148, 1995–2026Source: 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.

6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K944004	Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) Summary page 1 …Class 892.1560 Ultrasonic pulsed echo imaging system I1 Predicate Device: Cathscanner I11 Imaging System cleared under K944004 on May 4, 1995; ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K963290 on August 6…	Endosonics Corp.	1995	—
*	K963290	Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging System Summary page 1 …evice: Cathscanner I11 Imaging System cleared under K944004 on May 4, 1995; ColorFlo Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K963290 on August 6, 1997; and the Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223 o…	Endosonics Corp.	1997	—
*	K965223	Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging System Summary page 1 …r Ultrasound Imaging System cleared under K963290 on August 6, 1997; and the Resolve Option for the Oracle InVision Intravascular Ultrasound Imaging System cleared under K965223 on June 29, 1998. JOMED Inc. purchased End2 sonics Corporation under which K944004, K963290 and K965223 were filed. Device Des…	Endosonics Corp.	1998	—

Also cleared against K944004: 4 other devices →

What descends from it? (648)

See all 648

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051920	Volcano S5 Imaging System, Model 804200-001	Volcano Corporation	2005	614
K061215	Volcano S51 Family of Imaging Systems	Volcano Corporation	2006	613
K060483	Volcano Angio-Ivus Mapping (Aim) System	Volcano Corporation	2006	31
K052348	IN Vision Gold with Spin Vision, Model 891 SV	Volcano Corporation	2005	29
K071554	Volcano S5/S5I Intravascular Imaging and Pressure System	Volcano Corporation	2008	28
K082229	S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System	Volcano Corporation	2008	25

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K051920 (Volcano Corporation, 2005) has gone furthest, with 614 descendants of its own.
4 other devices also cite its predicate K944004.

How does its category compare?

All DXK devices

DXK Echocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXK

1in 2018

2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXK

Too few DXK 510(k)s in any year since 2007 to give a median.

Recalls per year · DXK

No recall names DXK since 2007.

Adverse event reports per year · DXK

1in 2024

2007high 4 (2018) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	1
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	3
2018	1	—	4
2019	0	—	1
2020	0	—	2
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

What is it indicated for?

In-VisionTMImaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information frop peripheral and coronary vaculature; flow- information can be an adjunct to other methods of estimating blood flow and blood perfusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031148: IN-Vision Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031148

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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