510(k) · Cleared

Cleared

Port Cassette

K032654510(k) TraditionalCleared Oct 9, 200342-day reviewClass II21 CFR 892.1630

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

Orex Computed Radiography, Ltd. · IXK System, Imaging, X-Ray, Electrostatic

Cleared on Oct 9, 2003 as substantially equivalent to K960834 (Eastman Kodak Company, 1996) after a 42-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.

Decided: Oct 9, 2003
Review: 42 days
Class: Class II
Product code: IXK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K960834 (1996). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK960834 Kodak EC-L CassetteEastman Kodak Company · 1996
This deviceK032654 Port CassetteOrex Computed Radiography, Ltd. · 2003
Descendant · cites it directly · 1 of its ownK073670 Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point…Orex Computed Radiography, Ltd. · 2008
Descendant · cites it directly · 1 of its ownK042779 Radiotherapy Solution Based on CRAgfa Corp. · 2004
Descendant · 2 generations on · 0 of its ownK192894 Vita Flex CR System with LLICarestream Health, Inc. · 2020
Descendant · 2 generations on · 0 of its ownK070920 Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc. · 2007

Most influential descendants

Showing 4 of 4 · See all

K073670Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR 260Orex Computed Radiography, Ltd. · 2008 · cites it directly1descendant
K042779Radiotherapy Solution Based on CRAgfa Corp. · 2004 · cites it directly1descendant
K192894Vita Flex CR System with LLICarestream Health, Inc. · 2020 · 2 generations on0descendants
K070920Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960834	Kodak EC-L Cassette	Eastman Kodak Company	1996	—
0 (this device)	K032654	Port Cassette	Orex Computed Radiography, Ltd.	2003	—
+1	K073670	Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR…	Orex Computed Radiography, Ltd.	2008	—
+1	K042779	Radiotherapy Solution Based on CR	Agfa Corp.	2004	—
+2	K192894	Vita Flex CR System with LLI	Carestream Health, Inc.	2020	—
+2	K070920	Fuji IP Cassette Type PC	Fujifilm Medical Systems U.S.A, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0
2008	1	0
2020	1	0

FIG. 1 — Lineage of K032654, 1996–2020Source: 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 IXK? 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

Get a 510(k) Report

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
*	K960834	Kodak EC-L Cassette Summary page 1 …DEVICES The legally marketed device to which equivalence is being claimed is: Kodak EC-L Cassette/EC-V Verification System for Portal Imaging (K960834) 6. DEVICEDESCRIPTION The PoRT Cassette is an optional cassette to be used with the PcCR Digital Imaging Devices…	Eastman Kodak Company	1996	—

Also cleared against K960834: 1 other device →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K073670	Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR 260	Orex Computed Radiography, Ltd.	2008	1
K042779	Radiotherapy Solution Based on CR	Agfa Corp.	2004	1

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.
Of its descendants, K073670 (Orex Computed Radiography, Ltd., 2008) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K960834.

How does its category compare?

All IXK devices

IXK System, Imaging, X-Ray, Electrostatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXK

1in 2011

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXK

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

Recalls per year · IXK

No recall names IXK since 2007.

Adverse event reports per year · IXK

No MAUDE report names IXK since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032654 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032654: Port Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032654

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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