510(k) · Cleared

Cleared

Nomos Slit Collimator (Beak)

K974310510(k) TraditionalCleared Feb 6, 199881-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

Nomos Corp. · IYE Accelerator, Linear, Medical

Cleared on Feb 6, 1998 as substantially equivalent to K953482 (Radionics Software Applications, Inc., 1995) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1993.

Decided: Feb 6, 1998
Review: 81 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K923522 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK923522 Linac-Based Sterotactic RadiosurgeryRadionics Software Applications, Inc. · 1993
This deviceK974310 Nomos Slit Collimator (Beak)Nomos Corp. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923522	Linac-Based Sterotactic Radiosurgery	Radionics Software Applications, Inc.	1993	—
0 (this device)	K974310	Nomos Slit Collimator (Beak)	Nomos Corp.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0

FIG. 1 — Lineage of K974310, 1993–1998Source: 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? (3)

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
*	K953482	Xknife-3 Summary page 1 …nt Name and_Address NOMOS Corporation 2591 Wexford Bayne Road Sewickley, PA 15143 2. Name of Predicate Devices' ¢ Radionics Software Applications, Inc. (RSA) X-Knife (K953482); RSA Linac-Based Stereotactic Radiosurgery System (K923522). o Blocks prepared at the user site using the Heustis Compu-Cutter (…	Radionics Software Applications, Inc.	1995	—
*	K923522	Linac-Based Sterotactic Radiosurgery Summary page 1 …ad Sewickley, PA 15143 2. Name of Predicate Devices' ¢ Radionics Software Applications, Inc. (RSA) X-Knife (K953482); RSA Linac-Based Stereotactic Radiosurgery System (K923522). o Blocks prepared at the user site using the Heustis Compu-Cutter (K 940145). 3. ‘ Classification The NOMOS Slit Collimator…	Radionics Software Applications, Inc.	1993	—
*	K940145	Compu-Cutter Therapeutic Shielding Cutting Device Summary page 1 …pplications, Inc. (RSA) X-Knife (K953482); RSA Linac-Based Stereotactic Radiosurgery System (K923522). o Blocks prepared at the user site using the Heustis Compu-Cutter (K 940145). 3. ‘ Classification The NOMOS Slit Collimator is an accessory to a medical charged-particle radiation therapy system or a bea…	Huestis Machine Corp.	1995	—

Also cleared against K953482: 2 other devices →

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?

None of the 3 ancestors has a recall.
2 other devices also cite its predicate K953482.

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?

The NOMOS Slit Collimator (BEAK™) is intended for use in Radiosurgery/Radiation Therapy to secondarily collimate the width of the radiation beam after it passes through the MIMiC® Multileaf Intensity Modulating Collimator (K940412). Several sizes of collimators will be provided with a slit width, at isocenter, ranging from 1 mm to 8 mm.

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/K974310 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974310: Nomos Slit Collimator (Beak).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974310

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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