510(k) · Cleared
ClearedDRF 4343
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Villa Sistemi Medicali S.P.A. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jun 4, 2008 as substantially equivalent to K053029 (Nical Spa, 2006) and 2 other predicates after a 69-day review. Its family tree reaches back 8 generations to 1980. 2 later devices descend from it.
- Decided
- Jun 4, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K801623 (1980). 61 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 6 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 5 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 4 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 3 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK080859 DRF 4343Villa Sistemi Medicali S.P.A. · 2008
- Descendant · cites it directly · 1 of its ownK103038 Duet DRFCmt Medical Technologies, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK202235 ArtPIX DRFCmt Medical Technologies, Ltd. · 2020
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 |
|---|---|---|---|---|---|
| −8 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −7 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −6 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −5 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −4 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −3 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −2 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −1 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| 0 (this device) | K080859 | DRF 4343 | Villa Sistemi Medicali S.P.A. | 2008 | — |
| +1 | K103038 | Duet DRF | Cmt Medical Technologies, Ltd. | 2011 | — |
| +2 | K202235 | ArtPIX DRF | Cmt Medical Technologies, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 12 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2020 | 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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K053029 | NDR+/Diva-DSummary page 1…ation for Stationary Digital X-Ray Systems 892.1630 Solid State x-ray Imaging system The DRF 4343 is compared with the following predicate devices: ¢ Nical NDR+/DIVA-D (K053029), * Siemens AXIOM Luminos dRF (K062623), + Shimadzu DAR7000 RADspeed SAFIRE (K050925). The DRF 4343 is Intended to capture digi… | 2006 |
| * | K062623 | Axiom Luminos DRFSummary page 1…ems 892.1630 Solid State x-ray Imaging system The DRF 4343 is compared with the following predicate devices: ¢ Nical NDR+/DIVA-D (K053029), * Siemens AXIOM Luminos dRF (K062623), + Shimadzu DAR7000 RADspeed SAFIRE (K050925). The DRF 4343 is Intended to capture digital images from a radiographic/ftuorosc… | 2007 |
| * | K050925 | Digital Radiography System Radspeed SafireSummary page 1…The DRF 4343 is compared with the following predicate devices: ¢ Nical NDR+/DIVA-D (K053029), * Siemens AXIOM Luminos dRF (K062623), + Shimadzu DAR7000 RADspeed SAFIRE (K050925). The DRF 4343 is Intended to capture digital images from a radiographic/ftuoroscopic system through & dynamic digital flat pane… | 2005 |
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 |
|---|---|---|---|
| K103038 | Duet DRF | 2011 | 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?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 18 of the 61 ancestors have a recall of any class.
- Of its descendants, K103038 (Cmt Medical Technologies, Ltd., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection.
This device is not intended for mammography use.
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/K080859 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080859: DRF 4343.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080859
Report an extraction error
Are you the manufacturer?
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