510(k) · Cleared
ClearedArtoscan S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosound Esaote, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jul 13, 1998 as substantially equivalent to K963262 (Biosound, Inc., 1997) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1991. 50 later devices descend from it.
- Decided
- Jul 13, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K911667 (1991). 13 ancestors in all. 50 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 1 generation backK963262 Artoscan MBiosound, Inc. · 1997
- This deviceK981358 Artoscan SBiosound Esaote, Inc. · 1998
- Descendant · cites it directly · 49 of its ownK990968 E-SCANBiosound Esaote, Inc. · 1999
- Descendant · 2 generations on · 48 of its ownK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- Descendant · 2 generations on · 47 of its ownK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- Descendant · 3 generations on · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004
- Descendant · 3 generations on · 43 of its ownK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K990968E-SCANBiosound Esaote, Inc. · 1999 · cites it directly49descendants
- K020164E-Scan XQBiosound Esaote, Inc. · 2002 · 2 generations on48descendants
- K032121Modification to E-Scan XQEsaote, S.p.A. · 2003 · 2 generations on47descendants
- K042236G-SCANEsaote, S.p.A. · 2004 · 3 generations on45descendants
- K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006 · 3 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −1 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| 0 (this device) | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| +1 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| +2 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| +2 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| +3 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| +3 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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 LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 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? (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 |
|---|---|---|---|
| * | K963262 | Artoscan MSummary page 1…ion Number: 807.92(a)(3 Esaote Hitachi Elscint Magnetic resonance diagnostic device System, Nuclear Magnetic Resonance Imaging 90LNH Predicate Device(s) Artoscan M K963262 AIRIS K945155 PRIMA ITG K970990 - Additional Substantial Equivalence Information is provided in the following substantial Equiv… | 1997 |
| * | K945155 | AIRISSummary page 1…7.92(a)(3 Esaote Hitachi Elscint Magnetic resonance diagnostic device System, Nuclear Magnetic Resonance Imaging 90LNH Predicate Device(s) Artoscan M K963262 AIRIS K945155 PRIMA ITG K970990 - Additional Substantial Equivalence Information is provided in the following substantial Equivalence Compari… | 1995 |
| * | K970990 | Gyrex Prima 1TG 1.0T Mri SystemSummary page 1…Hitachi Elscint Magnetic resonance diagnostic device System, Nuclear Magnetic Resonance Imaging 90LNH Predicate Device(s) Artoscan M K963262 AIRIS K945155 PRIMA ITG K970990 - Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. 200/ H… | 1997 |
What descends from it? (50)
See all 501 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990968 | E-SCAN | 1999 | 49 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K990968 (Biosound Esaote, Inc., 1999) has gone furthest, with 49 descendants of its own.
- 2 other devices also cite its predicate K963262.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
What is it indicated for?
The Artoscan S is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and…
Read the full statement (99 words)
The Artoscan S is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
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/K981358 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981358: Artoscan S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981358
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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