510(k) · Cleared

Cleared

Model R302DACS/a Automatic X-Ray Collimator

K072780510(k) TraditionalCleared Nov 26, 200759-day reviewClass II21 CFR 892.1610

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

Ralco S.R.L. · IZW Collimator, Automatic, Radiographic

Cleared on Nov 26, 2007 as substantially equivalent to K820306 (Tecnomed, Inc., 1982) and 3 other predicates after a 59-day review. Its family tree reaches back 3 generations to 1999. 2 later devices descend from it.

Decided: Nov 26, 2007
Review: 59 days
Class: Class II
Product code: IZW
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K990423 (1999). 6 ancestors in all, the oldest K820306 (1982). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK990423 Philips Nicol Collimator FamilyPhilips Medical Systems, Inc. · 1999
2 generations backK031597 Dunlee Format Collimator FamilyPhilips Medical Systems North America Co. · 2003
1 generation backK050092 R605 Facs CollimeterOmega Medical Imaging, Inc. · 2005
This deviceK072780 Model R302DACS/a Automatic X-Ray CollimatorRalco S.R.L. · 2007
Descendant · cites it directly · 0 of its ownK091517 Ralco, Model R225 AcsRalco S.R.L. · 2009
Descendant · cites it directly · 0 of its ownK083029 Model R605DASM Automatic X-Ray CollimatorRalco S.R.L. · 2008

Most influential descendants

Showing 2 of 2 · See all

K091517Ralco, Model R225 AcsRalco S.R.L. · 2009 · cites it directly0descendants
K083029Model R605DASM Automatic X-Ray CollimatorRalco S.R.L. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K990423	Philips Nicol Collimator Family	Philips Medical Systems, Inc.	1999	—
−2	K031597	Dunlee Format Collimator Family	Philips Medical Systems North America Co.	2003	—
−1	K050092	R605 Facs Collimeter	Omega Medical Imaging, Inc.	2005	—
0 (this device)	K072780	Model R302DACS/a Automatic X-Ray Collimator	Ralco S.R.L.	2007	—
+1	K091517	Ralco, Model R225 Acs	Ralco S.R.L.	2009	—
+1	K083029	Model R605DASM Automatic X-Ray Collimator	Ralco S.R.L.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	2	0
1990	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0

FIG. 1 — Lineage of K072780, 1999–2009Source: 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 IZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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? (4)

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
*	K820306	Ralco Collimator, Automatic Radiographic Summary page 1 …, Product Code IZW Common/Usual Name: Automatic X-Ray Collimator. 2. Equivalent legally marketed devices: Ralco Collimator, Automatic Radiographic, Teenomed, Inc, K820306 and K827124 (Manufactured by Ralco but sold in the US by Tecnomed); Advantech Model R600/800 series collimators manufactured b…	Tecnomed, Inc.	1982	—
*	K827124	Ralco Collimator, Automatic, Radiographic Summary page 1 …de IZW Common/Usual Name: Automatic X-Ray Collimator. 2. Equivalent legally marketed devices: Ralco Collimator, Automatic Radiographic, Teenomed, Inc, K820306 and K827124 (Manufactured by Ralco but sold in the US by Tecnomed); Advantech Model R600/800 series collimators manufactured by Ralco SRL…	Tecnomed, Inc.	1982	—
*	K904182	R-800-SF Summary page 1 …nomed, Inc, K820306 and K827124 (Manufactured by Ralco but sold in the US by Tecnomed); Advantech Model R600/800 series collimators manufactured by Ralco SRL under K904182; Omega Medical Imaging Model R605FACS, K050092. 3. Indications for Use (intended use): Model R302DACS/A Automatic X-RAY Colli…	Advantech	1990	—
*	K050092	R605 Facs Collimeter Summary page 1 …y Ralco but sold in the US by Tecnomed); Advantech Model R600/800 series collimators manufactured by Ralco SRL under K904182; Omega Medical Imaging Model R605FACS, K050092. 3. Indications for Use (intended use): Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiogr…	Omega Medical Imaging, Inc.	2005	—

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
K091517	Ralco, Model R225 Acs	Ralco S.R.L.	2009	0
K083029	Model R605DASM Automatic X-Ray Collimator	Ralco S.R.L.	2008	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?

The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K091517 (Ralco S.R.L., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All IZW devices

IZW Collimator, Automatic, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · IZW

2in 2010

2007high 2 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZW

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

Recalls per year · IZW

1in 2011

2007high 1 (2007) · low 0 (2009)2026

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

Adverse event reports per year · IZW

1in 2024

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code IZW, 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	2	—	1	2
2008	1	—	1	0
2009	2	—	0	0
2010	2	—	0	1
2011	0	—	1	1
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	1
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072780 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072780: Model R302DACS/a Automatic X-Ray Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072780

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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