510(k) · Cleared

Cleared

SCAN300FP / Retropan (VDC)

K051664510(k) TraditionalCleared Jul 20, 200528-day reviewClass II21 CFR 872.1800

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

Oy Ajat, Ltd. · MUH System, X-Ray, Extraoral Source, Digital

Cleared on Jul 20, 2005 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Jul 20, 2005
Review: 28 days
Class: Class II
Product code: MUH
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK051664 SCAN300FP / Retropan (VDC)Oy Ajat, Ltd. · 2005
Descendant · cites it directly · 0 of its ownK060149 Sunipan Imaging System & AccessoriesSuni Medical Imaging, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K060149Sunipan Imaging System & AccessoriesSuni Medical Imaging, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K051664	SCAN300FP / Retropan (VDC)	Oy Ajat, Ltd.	2005	—
+1	K060149	Sunipan Imaging System & Accessories	Suni Medical Imaging, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K051664, 2005–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in MUH? 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 MUH device

#1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060149	Sunipan Imaging System & Accessories	Suni Medical Imaging, Inc.	2006	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, K060149 (Suni Medical Imaging, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MUH devices

MUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUH

3in 2025

2007high 12 (2015) · low 3 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUH

159in 2025

2007high 174 (2010) · low 29 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUH

1in 2015

2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MUH

1in 2025

2007high 12 (2009) · low 0 (2007)2025

MAUDE reports naming product code MUH, 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	11	48	0	0
2008	8	64	1	0
2009	9	88	2	12
2010	9	174	0	9
2011	10	89	0	0
2012	9	81	0	5
2013	9	172	1	1
2014	8	168	1	5
2015	12	111	1	3
2016	6	47	0	1
2017	9	84	0	4
2018	3	29	0	10
2019	5	64	0	6
2020	5	36	0	0
2021	10	80	0	1
2022	7	57	0	0
2023	11	57	0	1
2024	4	144	0	0
2025	3	159	0	1
2026	2	—	0	—

What is it indicated for?

The Scan300fp / Recropan (VDOC Digital X-ray Conversion Kit is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.

The Scan300fp sensor produces instant digital images. The Scan300fp allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software. #KO 12439, which gives post processing capabilities to enhance images.

It is faster to obtain images with the Scan300fp / Retrofit (VDC] than with conventional film since no chemical nor any other type of processing is required.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K051664 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051664: SCAN300FP / Retropan (VDC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051664

Report an extraction error

Are you the manufacturer?

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