510(k) · Cleared
ClearedS-Scan, Model 9800020010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote, S.p.A. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Apr 5, 2010 as substantially equivalent to K080968 (Esaote, S.p.A., 2008) after a 27-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Apr 5, 2010
- Review
- 27 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K911667 (1991). 44 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 6 generations between
- 3 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 2 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 1 generation backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- This deviceK100670 S-Scan, Model 9800020010Esaote, S.p.A. · 2010
Show all 10 generations
- Root · 10 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 9 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 8 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 7 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 6 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 5 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 4 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 3 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 2 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 1 generation backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- This deviceK100670 S-Scan, Model 9800020010Esaote, S.p.A. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −9 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −8 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −7 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −6 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −5 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −4 | 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 | — |
| −2 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −1 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| 0 (this device) | K100670 | S-Scan, Model 9800020010 | Esaote, S.p.A. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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 |
|---|---|---|---|
| * | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaSummary page 2…oil to the S-scan system, reflected in this Special 510O(k), does not alter the fundamental scientific technology of the S-scan system, the predicate device, cleared via K080968. Esaote, S~pA S-Scan Special 510(k) Page 12 of 336 DEPAR… | 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 19 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 44 ancestors have a recall of any class.
- 6 other devices also cite its predicate K080968.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral…
Read the full statement (130 words)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.
S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (Ti), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100670: S-Scan, Model 9800020010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100670
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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