510(k) · Cleared
ClearedIGAR System (1001.A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insight Medbotics, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 20, 2023 as substantially equivalent to K100113 (Sentinelle Medical, Inc., 2010) after a 244-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jul 20, 2023
- Review
- 244 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993776 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK993776 Obc-300 Breast Array CoilMri Devices Corp. · 1999
- 2 generations backK060873 Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array…Sentinelle Medical, Inc. · 2006
- 1 generation backK100113 Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for…Sentinelle Medical, Inc. · 2010 · Recalled
- This deviceK223484 IGAR System (1001.A)Insight Medbotics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993776 | Obc-300 Breast Array Coil | Mri Devices Corp. | 1999 | — |
| −2 | K060873 | Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE… | Sentinelle Medical, Inc. | 2006 | — |
| −1 | K100113 | Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri… | Sentinelle Medical, Inc. | 2010 | 1 |
| 0 (this device) | K223484 | IGAR System (1001.A) | Insight Medbotics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K100113 | Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System…Summary page 4…evice Classification and Product Code Magnetic resonance diagnostic device, 21 CFR 892.1000, Class II, MOS Predicate Devices Vanguard Breast MRI System (K100113)-Primary Predicate Affirm Prone Biopsy System (K153486)- Reference device Indications for Use The IGAR System is… | 2010 |
| † | K153486 | Affirm Prone Biopsy System | 2016 |
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 24 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K100113.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The IGAR System is intended to acquire magnetic resonance (MR) images of the breast anatomy and permits access to the breast for biopsy and localization procedures. A front breast restraint immobilizes the patient’s breast to permit three-dimensional MR imaging to identify the location of the breast lesion(s) for the purposes of selecting a target for biopsy. The IGAR System guides a breast biopsy tool to the target location of the breast from which a biopsy can be obtained. The IGAR System is intended to be used by qualified professionals.
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/K223484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223484: IGAR System (1001.A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223484
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