510(k) · Cleared
Cleared3DHJD Camera System Model
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Systems Group, A Division of Viking Systems · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 30, 2010 as substantially equivalent to K021290 (Vista Medical Technologies, Inc., 2002) and 1 other predicate after a 62-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Aug 30, 2010
- Review
- 62 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K923160 (1992). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
- 5 generations backK961182 3D ScopeOktas · 1996
- 4 generations backK970214 3 Dimensional Video EndoscopeOktas · 1997
- 3 generations backK990635 Vista Stereoscope SystemVista Medical Technologies, Inc. · 1999
- 2 generations backK020301 Modification to Vista Stereoscope SystemVista Medical Technologies, Inc. · 2002
- 1 generation backK021290 Vista Visualization System, Model 9000, Vista Visualization System…Vista Medical Technologies, Inc. · 2002
- This deviceK101810 3DHJD Camera System ModelVision Systems Group, A Division of Viking Systems · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K923160 | 3DSCOPE | American Surgical Technologies Corp. | 1992 | — |
| −5 | K961182 | 3D Scope | Oktas | 1996 | — |
| −4 | K970214 | 3 Dimensional Video Endoscope | Oktas | 1997 | — |
| −3 | K990635 | Vista Stereoscope System | Vista Medical Technologies, Inc. | 1999 | — |
| −2 | K020301 | Modification to Vista Stereoscope System | Vista Medical Technologies, Inc. | 2002 | — |
| −1 | K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice… | Vista Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K101810 | 3DHJD Camera System Model | Vision Systems Group, A Division of Viking Systems | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice Activation…Summary page 1…Endoscope and/Or Accessories, 21 CFR 876.1500 Connnonl/Uszalnomues: Endoscope and Accessories. KOG Predicate Devices: K021290 Visualization System KOS 1585 3 Chip Endloscopy System Device Description: The… | 2002 |
| * | K081585 | Endoscopy Video Camera SystemSummary page 1…Thle proposed 3DHD Video Camera System is substantially equivalent to the Currently legally marketed Visualization System (K02 1290) and the 3 Chip Endoscopy System (K081585) in terms of intended use, operating principle. and basic design. Testing demonstrates that the modifications proposed herein… | 2008 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 15 ancestors has a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
For use in all types of video assisted minimally invasive procedures including: general surgery, gynecologic, thoracic, urologic, bariatric, spinal, ENT and as an aid in visualization of cardiac structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101810: 3DHJD Camera System Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101810
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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