510(k) · Cleared

Cleared

Pvmed DDR 2520 Digital Imaging System

K072766510(k) TraditionalCleared Dec 11, 200774-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

Portavision Medical · IXK System, Imaging, X-Ray, Electrostatic

Cleared on Dec 11, 2007 as substantially equivalent to K024147 (Varian Medical Systems, Inc., 2003) and 1 other predicate after a 74-day review. Its family tree reaches back 5 generations to 1981.

Decided: Dec 11, 2007
Review: 74 days
Class: Class II
Product code: IXK
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K803130 (1981). 18 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
4 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
3 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
2 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
1 generation backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
This deviceK072766 Pvmed DDR 2520 Digital Imaging SystemPortavision Medical · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K803130	Multix U. Bucky Table X-Ray Unit	Siemens Corp.	1981	1
−4	K971452	Multix Top/Pro Radiographic X-Ray Table	Siemens Medical Solutions USA, Inc.	1997	8
−3	K983732	Thorax FD and Multix FD	Siemens Medical Solutions USA, Inc.	1999	1
−2	K992794	Stingray DR, Model 1	Infimed, Inc.	1999	—
−1	K024147	Paxscan 4030 Medical Digital Imaging System	Varian Medical Systems, Inc.	2003	—
0 (this device)	K072766	Pvmed DDR 2520 Digital Imaging System	Portavision Medical	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1988	1	0
1991	1	0
1992	1	0
1994	2	0
1995	2	0
1997	1	0
1998	3	0
2000	1	0

FIG. 1 — Lineage of K072766, 1981–2007Source: 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

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What was it cleared against? (2)

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
*	K024147	Paxscan 4030 Medical Digital Imaging System Summary page 1 …ay imaging system x-ray system). IXK at 21 CFR Part 892.1630 Legally marketed devices K024147 to which the device is Paxscan 4030 Medical Digital Imaging Systems substantially equivalent: Varian Media…	Varian Medical Systems, Inc.	2003	—
*	K904519	Agfa Diagnostic Center (Adc) Summary page 1 …he device is Paxscan 4030 Medical Digital Imaging Systems substantially equivalent: Varian Medial Systems, Inc. K904519A ADC-70 Agfa Medical Systems Description of the device:…	Enhanced Imaging Technologies, Inc.	1991	—

Also cleared against K024147: 5 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?

The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
10 of the 18 ancestors have a recall of any class.
5 other devices also cite its predicate K024147.

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. 2007, this device’s year, is highlighted.

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 PortaVision PVMed DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy. (The system is not intended to be use for mammography). It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This imager is intended for incorporation into a complete x-ray system by a qualified equipment manufacturer. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072766 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072766: Pvmed DDR 2520 Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072766

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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