510(k) · Cleared

Cleared

Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay

K162002510(k) TraditionalCleared Nov 1, 2016104-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

Zdi, Solutions, LLC · IYE Accelerator, Linear, Medical

Cleared on Nov 1, 2016 as substantially equivalent to K982624 (Med-Tec,Inc., 1998) after a 104-day review. Its family tree reaches back 1 generation to 1998.

Decided: Nov 1, 2016
Review: 104 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K982624 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK982624 Moldcare Head & Neck Cushion, Model # MT-Acl-14242Med-Tec,Inc. · 1998
This deviceK162002 Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square…Zdi, Solutions, LLC · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982624	Moldcare Head & Neck Cushion, Model # MT-Acl-14242	Med-Tec,Inc.	1998	—
0 (this device)	K162002	Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System…	Zdi, Solutions, LLC	2016	—

FIG. 1 — Lineage of K162002, 1998–2016Source: 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? (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	Applicant	Decided	Recalls
*	K982624	Moldcare Head & Neck Cushion, Model # MT-Acl-14242 Summary page 4 …ged-Particle Radiation Therapy System Regulatory Class: II Product Code: IYE III. Predicate Devices Klarity Medical Products, Inc. Klarity Breast Board (R610), K982624 This predicate device has not been subject to a design-related recall. IV. Device Description The Z-Tilt is a patient-…	Med-Tec,Inc.	1998	—
†	K951808	Med-Tec Redi-Foam	Medtec, Inc.	1995	—
†	K935300	Vac-Lok Immobilization System	Medtec, Inc.	1994	—

Also cleared against K982624: 3 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?

Its one ancestor has no recall.
3 other devices also cite its predicate K982624.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

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?

ZDi Z-Tilt is intended for use by trained medical professionals for patient support and immobilization during external beam radiation therapy in clinics and hospitals. The Z-Tilt and accessories provide patient comfort and stability in various positions for radiation treatment. The Z-Tilt and is used in the treatment of cancer under the supervision and administration of licensed doctors and clinical staff.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162002 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162002: Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162002

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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