510(k) · Cleared

Cleared

The MCP-70-SE System

K844180510(k) TraditionalCleared Feb 1, 198598-day reviewClass II21 CFR 892.5900

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

Ellis Pharmaceutical Consulting, Inc. · KQA Device, Beam Limiting, X-Ray, Therapeutic

Cleared on Feb 1, 1985 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Feb 1, 1985
Review: 98 days
Class: Class II
Product code: KQA
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK844180 The MCP-70-SE SystemEllis Pharmaceutical Consulting, Inc. · 1985
Descendant · cites it directly · 0 of its ownK972016 Autimo 2.5-D and Autimo 3-DC.L. Mcintosh & Assoc., Inc. · 1997
Descendant · cites it directly · 0 of its ownK971001 AutimoMedizintechnik, GmbH · 1997

Most influential descendants

Showing 2 of 2 · See all

K972016Autimo 2.5-D and Autimo 3-DC.L. Mcintosh & Assoc., Inc. · 1997 · cites it directly0descendants
K971001AutimoMedizintechnik, GmbH · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K844180	The MCP-70-SE System	Ellis Pharmaceutical Consulting, Inc.	1985	—
+1	K972016	Autimo 2.5-D and Autimo 3-D	C.L. Mcintosh & Assoc., Inc.	1997	—
+1	K971001	Autimo	Medizintechnik, GmbH	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0

FIG. 1 — Lineage of K844180, 1985–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K972016	Autimo 2.5-D and Autimo 3-D	C.L. Mcintosh & Assoc., Inc.	1997	0
K971001	Autimo	Medizintechnik, GmbH	1997	0

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?

Of its descendants, K972016 (C.L. Mcintosh & Assoc., Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KQA devices

KQA Device, Beam Limiting, X-Ray, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KQA

FDA has decided no KQA device since 2007.

Median 510(k) review, days · KQA

Too few KQA 510(k)s in any year since 2007 to give a median.

Recalls per year · KQA

No recall names KQA since 2007.

Adverse event reports per year · KQA

No MAUDE report names KQA since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K844180 · printed Nov 6, 2026

Cite this page

510(k) Report. “K844180: The MCP-70-SE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844180

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026