510(k) · Cleared
ClearedVista Orpc with Infomatix Intraop Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vista Medical Technologies, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 12, 1999 as substantially equivalent to K973436 (Vista Medical Technologies, Inc., 1997) after an 87-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973436 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK973436 Vista Head Mounted DisplayVista Medical Technologies, Inc. · 1997
- This deviceK991303 Vista Orpc with Infomatix Intraop SoftwareVista Medical Technologies, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK021290 Vista Visualization System, Model 9000, Vista Visualization System…Vista Medical Technologies, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK101810 3DHJD Camera System ModelVision Systems Group, A Division of Viking Systems · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973436 | Vista Head Mounted Display | Vista Medical Technologies, Inc. | 1997 | — |
| 0 (this device) | K991303 | Vista Orpc with Infomatix Intraop Software | Vista Medical Technologies, Inc. | 1999 | — |
| +1 | K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice… | Vista Medical Technologies, Inc. | 2002 | — |
| +2 | K101810 | 3DHJD Camera System Model | Vision Systems Group, A Division of Viking Systems | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K973436 | Vista Head Mounted DisplaySummary page 1…raOp COMMON NAME Stereo Viewing Monitor Display for Endoscopic Visualization PREDICATE DEVICE Vista Head Mounted Display System With Infomatix Software, Version 1.0 - K973436 Vista Medical Technologies, Inc. 134 Flanders Road Westborough, MA 01581 When compared to the originally submitted device, th… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice Activation… | 2002 | 1 |
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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Vista ORPC with Infomatix IntraOp Software is designed to display video images while mounted on the users’ head. These video images can be captured, redisplayed as still images, and exported to removable media. The ORPC with Infomatix IntraOp software is designed to be used as a personal replacement for surgical monitors.
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/K991303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991303: Vista Orpc with Infomatix Intraop Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991303
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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