510(k) · Cleared
ClearedPinpoint Stereotactic Head and Neck Localizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aktina Medical Physics Corp. · IYE Accelerator, Linear, Medical
Cleared on Jan 25, 2011 as substantially equivalent to K081935 (Aktina Medical Physics Corp., 2008) after a 46-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jan 25, 2011
- Review
- 46 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934523 (1995). 11 ancestors in all, the oldest K934657 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK934523 Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth…Radionics, Inc. · 1995
- 3 generations backK962155 Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc. · 1996
- 2 generations backK991237 Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc. · 1999 · Recalled
- 1 generation backK081935 Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008
- This deviceK103616 Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934523 | Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth… | Radionics, Inc. | 1995 | — |
| −3 | K962155 | Gill-Thomas-Cosman (GTC) Dental Tray | Radionics Software Applications, Inc. | 1996 | — |
| −2 | K991237 | Xplan-2 with Head and Neck Localizer, Model HNL | Radionics, Inc. | 1999 | 1 |
| −1 | K081935 | Stereotactic Head and Neck Localizer, Model 50-100 | Aktina Medical Physics Corp. | 2008 | — |
| 0 (this device) | K103616 | Pinpoint Stereotactic Head and Neck Localizer | Aktina Medical Physics Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K081935 | Stereotactic Head and Neck Localizer, Model 50-100Summary page 1…50, "Medical charged-particle radiation therapy system." The product code is IYE. 3. Predicate Device Stereotactic Head and Neck Localizer, K08 1935, manufactured by Aktina Medical Corporation, 360 North Route 9 W, Congers, New York, 10920 4. Description… | 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 16 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 11 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
This product is used for patients who require external beam stereotactic radiation therapy of the head and neck region or radiosurgery of the cranial region. The system provides cranial and head and neck fixation and stereotactic localization with automatic software fiducial localization. It is intended to be used during both Computed Tomography (acquisition of the imaging series used for the patient's treatment plan) and each of the patient radiation treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103616: Pinpoint Stereotactic Head and Neck Localizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103616
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