510(k) · Cleared
Recalled · 2009I-Cat Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Sciences Intl., Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Jul 3, 2006 as substantially equivalent to K003787 (Aperio Services, LLC, 2001) and 1 other predicate after a 56-day review. Its family tree reaches back 2 generations to 1997. 31 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 3, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- MUH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973598 (1997). 4 ancestors in all. 31 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 1 generation backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- This deviceK061284 I-Cat ScannerImaging Sciences Intl., Inc. · 2006
- Descendant · cites it directly · 24 of its ownK073350 Scanora 3DSoredex Palodex Group OY · 2007
- Descendant · 2 generations on · 21 of its ownK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- Descendant · 3 generations on · 11 of its ownK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- Descendant · 3 generations on · 8 of its ownK122018 OP300Palodex Group OY · 2012
- Descendant · 4 generations on · 7 of its ownK133544 OP300Palodex Group OY · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K073350Scanora 3DSoredex Palodex Group OY · 2007 · cites it directly24descendants
- K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010 · 2 generations on21descendants
- K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011 · 3 generations on11descendants
- K122018OP300Palodex Group OY · 2012 · 3 generations on8descendants
- K133544OP300Palodex Group OY · 2014 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −1 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| 0 (this device) | K061284 | I-Cat Scanner | Imaging Sciences Intl., Inc. | 2006 | — |
| +1 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| +2 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| +3 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| +3 | K122018 | OP300 | Palodex Group OY | 2012 | — |
| +4 | K133544 | OP300 | Palodex Group OY | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 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? (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 |
|---|---|---|---|
| * | K003787 | Newtom QR-DVT 9000Summary page 2…QR - DVT 9000 Manufacturer: NIM s.r.1. Via Silverstrini, 20 37135 Verona Italy 510 (k) Number: K003787 Device: 3D Accu-l-tomo XYZ Slice View Tomograph Manufacturer: J. Morita Manufacturing Corporation… | 2001 |
| * | K030450 | 3D Accu-I-Tomo Xyz Slice View TomographSummary page 2…raph Manufacturer: J. Morita Manufacturing Corporation 680 Higashihama Minami-cho, Fushimi-ku Japan 510 (k) Number: K030450 Description Of The Device: The i-CAT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray seq… | 2003 |
What descends from it? (31)
See all 314 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2009 | Not classified | Z-1265-2009 | Nonconforming Material/Component | faulty calibration |
| Mar 19, 2008 | Not classified | Z-1646-2008 | Error in labeling | Incorrect scatter information in the manual. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K073350 (Soredex Palodex Group OY, 2007) has gone furthest, with 24 descendants of its own.
- 5 other devices also cite its predicate K003787.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061284 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061284: I-Cat Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061284
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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