510(k) · Cleared

Cleared

Magnetic Resonance Diagnostic Device, Model CG-KFC18-H150-AP - Knee/Foot/Ankle Coil

K071847510(k) TraditionalCleared Jul 23, 200718-day reviewClass II21 CFR 892.1000

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

Shanghai Chenguang Medical Technologies Co, Ltd. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jul 23, 2007 as substantially equivalent to K991724 (Medical Advances, Inc., 1999) and 2 other predicates after an 18-day review. Its family tree reaches back 1 generation to 1999.

Decided: Jul 23, 2007
Review: 18 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K991724 (1999). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK991724 Quadrature Lower Extremity Coil, Model 473PH-64Medical Advances, Inc. · 1999
This deviceK071847 Magnetic Resonance Diagnostic Device, Model CG-KFC18-H150-AP -…Shanghai Chenguang Medical Technologies Co, Ltd. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991724	Quadrature Lower Extremity Coil, Model 473PH-64	Medical Advances, Inc.	1999	—
0 (this device)	K071847	Magnetic Resonance Diagnostic Device, Model CG-KFC18-H150-AP - Knee/Foot/Ankle…	Shanghai Chenguang Medical Technologies Co, Ltd.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0

FIG. 1 — Lineage of K071847, 1999–2007Source: 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 MOS? 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 MOS device

#1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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? (3)

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
*	K991724	Quadrature Lower Extremity Coil, Model 473PH-64 Summary page 2 …te Devices (Legally Marketed Devices) The predicate devices for the Knee-FoofAnkle coil 4ch 1.5T are the 473PH- 64Quadrature lower extremity coil,with 510(k) number of K991724, Model 1300GE- 64 - Pediatric Positioner with 5 10(k) number ofk030317 and Model PHS-63 Pediatric Head and Spine Array Coil with…	Medical Advances, Inc.	1999	—
*	K030317	Model 1300GE-64: Pediatric Positioner Summary page 2 …nee-FoofAnkle coil 4ch 1.5T are the 473PH- 64Quadrature lower extremity coil,with 510(k) number of K991724, Model 1300GE- 64 - Pediatric Positioner with 5 10(k) number ofk030317 and Model PHS-63 Pediatric Head and Spine Array Coil with 510(k) number of k003655. Device Description The Knee/Foot/Ankle Coil…	Midwest Rf, LLC	2003	—
*	K003655	PHS-63 Pediatric Head and Spine Array Coil Summary page 2 …10(k) number of K991724, Model 1300GE- 64 - Pediatric Positioner with 5 10(k) number ofk030317 and Model PHS-63 Pediatric Head and Spine Array Coil with 510(k) number of k003655. Device Description The Knee/Foot/Ankle Coil consists of three parts, bottom part with a cable and a base plate, a knee part an…	Mri Devices Corp.	2001	—

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?

None of the 3 ancestors has a recall.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MOS

3in 2025

2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007high 178 (2019) · low 19 (2007)2026

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

Recalls per year · MOS

13in 2024

2007high 13 (2024) · low 0 (2007)2026

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

Adverse event reports per year · MOS

2in 2025

2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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	16	19	0	4
2008	19	33	2	2
2009	10	43	0	5
2010	16	78	1	13
2011	25	57	0	7
2012	15	49	1	12
2013	7	87	0	10
2014	12	60	0	4
2015	6	58	2	5
2016	11	42	0	7
2017	9	63	0	9
2018	10	30	0	7
2019	3	178	8	8
2020	5	51	1	2
2021	4	41	0	3
2022	11	79	0	5
2023	10	59	0	4
2024	10	39	13	8
2025	3	59	0	2
2026	10	45	0	—

What is it indicated for?

The Knee/Foot/Ankle Coil is a receive-only coil, used for obtaining diagnostic images of knee, foot, ankle and lower leg in conjunction with a PHILIPS 1.5T MRI scanner. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071847 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071847: Magnetic Resonance Diagnostic Device, Model CG-KFC18-H150-AP - Knee/Foot/Ankle Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071847

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