510(k) · Cleared
ClearedAida with Dicom and HL7 Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Apr 4, 2005 as substantially equivalent to K973131 (Siemens Medical Solutions USA, Inc., 1997) after a 123-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it.
- Decided
- Apr 4, 2005
- Review
- 123 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924178 (1993). 6 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
- 2 generations backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
- 1 generation backK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
- This deviceK043324 Aida with Dicom and HL7 InterfaceKARL STORZ Endoscopy-America, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK151737 MedicVOD SystemOrpheus Medical, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK102949 Colonoscopy AssistantSti Medical Systems, LLC · 2011
- Descendant · cites it directly · 0 of its ownK093603 Storm-Base 2.0KARL STORZ Endoscopy-America, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013 · cites it directly1descendant
- K151737MedicVOD SystemOrpheus Medical, Ltd. · 2016 · 2 generations on0descendants
- K102949Colonoscopy AssistantSti Medical Systems, LLC · 2011 · cites it directly0descendants
- K093603Storm-Base 2.0KARL STORZ Endoscopy-America, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924178 | Medvision (TM) Imaging Software | Evergreen Technologies, Inc. | 1993 | — |
| −2 | K970064 | Amicas Web/Intranet Image Server | Autocyt Group, Inc. | 1997 | — |
| −1 | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| 0 (this device) | K043324 | Aida with Dicom and HL7 Interface | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| +1 | K123426 | Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS | Orpheus Medical, Ltd. | 2013 | — |
| +2 | K151737 | MedicVOD System | Orpheus Medical, Ltd. | 2016 | — |
| +1 | K102949 | Colonoscopy Assistant | Sti Medical Systems, LLC | 2011 | — |
| +1 | K093603 | Storm-Base 2.0 | KARL STORZ Endoscopy-America, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 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 |
|---|---|---|---|
| * | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Summary page 2…System via HL7 protocol. Substantial Equivalence: The Karl Storz AIDA/DICOMIHL7 is substantially equivalent to the predicate device (SIENET MagicWeb and Magic Link I: K973131) since the basic features and intended uses are the same. The minor differences between the Karl Storz AIDAIDICOM/HL7 and the pre… | 1997 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K123426 (Orpheus Medical, Ltd., 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K973131.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
This software is intended for use by qualified personnel in the Operating Room and Nurses Station. The Advanced Image and Data Archiving System (AIDA) is a Windows® based still/video image capturing, archiving, documentation system and recording of audio sequences and patient data during a procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference…
Read the full statement (145 words)
This software is intended for use by qualified personnel in the Operating Room and Nurses Station. The Advanced Image and Data Archiving System (AIDA) is a Windows® based still/video image capturing, archiving, documentation system and recording of audio sequences and patient data during a procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis.
It is also a Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA system the Storz Application Manager software (SAM) enables the selection and integrations of AIDA functions with various compatible applications, such as Karl Storz's Storz Communication Bus (SCB) or other third party image capturing devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043324 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043324: Aida with Dicom and HL7 Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043324
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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