510(k) · Cleared
ClearedIntegrated Visualization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urohealth, Inc. · FCW Light Source, Fiberoptic, Routine
Cleared on Mar 12, 1997 as substantially equivalent to K951647 (Welch Allyn, Inc., 1995) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Mar 12, 1997
- Review
- 22 days
- Class
- Class II
- Product code
- FCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951647 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK951647 Welch Allyn HI - Lux IlluminatorWelch Allyn, Inc. · 1995
- This deviceK970598 Integrated Visualization SystemUrohealth, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951647 | Welch Allyn HI - Lux Illuminator | Welch Allyn, Inc. | 1995 | — |
| 0 (this device) | K970598 | Integrated Visualization System | Urohealth, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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 FCW? 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
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 | Decided |
|---|---|---|---|
| * | K951647 | Welch Allyn HI - Lux IlluminatorSummary page 1…Light Source, Camera, and Monitor in one unit PREDICATE DEVICE 1. Device Name: Welch Allyn Hi - Lux Illuminator Classification: II Manufacturer: Welch Allyn 510(k) #: K951647 2. Device Name: Integrated Video System Classification: II Manufacturer: BEI Medical Systems Company, Inc. 510¢k) #: unknown 3.… | 1995 |
| * | K963046 | EndocamSummary page 1…Manufacturer: BEI Medical Systems Company, Inc. 510¢k) #: unknown 3. Device Name: Camera, Accessory to endoscope Classification: I Manufacturer: Corin U.S.A. 510(k) #: K963046 DEVICE DESCRIPTION 000057 (e U8 - pro] UROHEALTH Systems, Inc. 510(k) Notification Costa Mesa, CA Integrated… | 1996 |
| * | — | Integrated Video System Named without a submission 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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K951647.
How does its category compare?
All FCW devicesFCW Light Source, Fiberoptic, Routine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FCW
Too few FCW 510(k)s in any year since 2007 to give a median.
Recalls per year · FCW
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCW
140in 2025
MAUDE reports naming product code FCW, 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 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 148 |
| 2010 | 1 | — | 0 | 713 |
| 2011 | 0 | — | 4 | 603 |
| 2012 | 2 | — | 0 | 77 |
| 2013 | 1 | — | 0 | 29 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 24 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 76 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 0 | 152 |
| 2021 | 0 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 179 |
| 2024 | 0 | — | 0 | 179 |
| 2025 | 0 | — | 0 | 140 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IVS is used in providing illumination for endoscopic procedures and transmitting an image from an endoscope to a viewing monitor, which is integral to the system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970598: Integrated Visualization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970598
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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