510(k) · Cleared

Cleared

Philips BV300 Series Release 2.1

K982706510(k) TraditionalCleared Sep 2, 199829-day reviewClass II21 CFR 892.1650

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

Philips Medical Systems, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

Cleared on Sep 2, 1998 as substantially equivalent to K953910 (Philips Medical Systems North America, Inc., 1995) after a 29-day review. Its family tree reaches back 1 generation to 1995.

Decided: Sep 2, 1998
Review: 29 days
Class: Class II
Product code: OXO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953910 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK953910 Philips BV 300 SeriesPhilips Medical Systems North America, Inc. · 1995 · Recalled
This deviceK982706 Philips BV300 Series Release 2.1Philips Medical Systems, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953910	Philips BV 300 Series	Philips Medical Systems North America, Inc.	1995	1
0 (this device)	K982706	Philips BV300 Series Release 2.1	Philips Medical Systems, Inc.	1998	—

FIG. 1 — Lineage of K982706, 1995–1998Source: 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 OXO? 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 OXO device

#1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K953910	Philips BV 300 Series Summary page 1 …devices. Substantial equivalence Information The BV300 Series Release 2.1 is a modification of, and substantially equivalent to, the BV300 Series Release 1, 510(k) No. K953910. Safety Information The BV300 Series Release 2.1 complies with the applicable portions of 21 CFR parts 1020.30/.31/.32 and volu…	Philips Medical Systems North America, Inc.	1995	1

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?

Its one ancestor has a recall.

How does its category compare?

All OXO devices

OXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OXO

4in 2025

2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OXO

97in 2025

2007high 213 (2019) · low 48 (2012)2026

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

Recalls per year · OXO

4in 2024

2007high 11 (2018) · low 0 (2007)2026

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

Adverse event reports per year · OXO

118in 2025

2007high 3,820 (2016) · low 0 (2007)2025

MAUDE reports naming product code OXO, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	0	—	0	0
2012	4	48	4	5
2013	2	—	3	41
2014	2	—	4	89
2015	1	—	0	97
2016	3	128	3	3,820
2017	4	57	4	1,697
2018	1	—	11	1,647
2019	3	213	0	1,297
2020	0	—	0	816
2021	2	—	0	554
2022	0	—	0	295
2023	0	—	0	275
2024	2	—	4	192
2025	4	97	0	118
2026	2	—	1	—

What is it indicated for?

The Philips BV 300 Series Release 2.1 systems are Mobile C-Arm X-Ray Systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. The series has been designed primarily for use in the operating theater.

The Philips BV300 Series Release 2.1 systems are intended for the same applications as the BV300 Series Release 1, i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the Operating Room.

This includes cerebral, thoracic, abdominal, peripheral, orthopedic and vascular procedures. The systems are also suited as a back-up for a fixed vascular X-ray system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982706 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982706: Philips BV300 Series Release 2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982706

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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