510(k) · Cleared

Cleared

Aktina Medicalphysics Corporation Mechanical Frontpointer

K990997510(k) TraditionalCleared Jun 22, 199989-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aktina Medical Physics Corp. · IYE Accelerator, Linear, Medical

Cleared on Jun 22, 1999 as substantially equivalent to K874558 (Philips Medical Systems, Inc., 1988) after an 89-day review. Its family tree reaches back 1 generation to 1988.

Decided: Jun 22, 1999
Review: 89 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K874558 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK874558 SL Series, SL 15, 18, 20 & 25Philips Medical Systems, Inc. · 1988
This deviceK990997 Aktina Medicalphysics Corporation Mechanical FrontpointerAktina Medical Physics Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K874558	SL Series, SL 15, 18, 20 & 25	Philips Medical Systems, Inc.	1988	—
0 (this device)	K990997	Aktina Medicalphysics Corporation Mechanical Frontpointer	Aktina Medical Physics Corp.	1999	—

FIG. 1 — Lineage of K990997, 1988–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K874558	SL Series, SL 15, 18, 20 & 25 Summary page 1 …920 Phone: 914-268-0101 FAX: 914-268-1700 Registration Number: 2436865 Name of Predicate Devices Sears Tape Measure and Elekta Oncology Systems Mechanical Frontpointer K874558. 1 Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates ta…	Philips Medical Systems, Inc.	1988	—
*	—	Sears Tape Measure Named without a submission number			—

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?

Its one ancestor has no recall.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)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?

Read the full statement (168 words)

In Radiation Therapy and Diagnostic Radiology, an ongoing quality assurance program is essential for ensuring the overall quality of patient care. As part of the overall quality assurance program daily, monthly and annual tests to validate machine output, field size indicators, and general machine geometry are performed. In order to obtain reproducible results, these tests must be performed under the same conditions, with the same physical parameters. Since machine output and field size are directly rclated to the geometry of the test conditions it is important that the distance from the beam source to the test device is consistent. The Aklina Medical Physics Corporation Mechanical Frontpointer is designed to provide this ability. By utilizing the fixed geometry of the accessory mount system on a linear accelerator, a rigid based for measuring distance can be obtained. The Mechanical Frontpointer presented in this notification functions exactly as a standard mechanical tape measure however by being attached to a frame which slides into the accessory mount a reproducible setup is ensured.

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/K990997 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990997: Aktina Medicalphysics Corporation Mechanical Frontpointer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990997

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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