Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263033

Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd.

Q: How to monitor Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd. and peer radiology records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd.: 510(k) cleared for Fussen Technology Co., Ltd. Its amount of 30 is below the median of 138 (10th percentile). Dated 35 days ago, it serves as a historical benchmark. Score 41/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 30 · 10th percentile of 414 FDAPulse records · 0.2x the median

Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K263033
Device	Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
Applicant	Fussen Technology Co., Ltd.
Specialty / panel	Radiology
Product code	OAS
Device class	2
Clearance type	Special
Decision	Substantially Equivalent
Received	2026-08-31
Decision date	2026-09-30
Review time (days)	30
Third-party review	No
Applicant location	Shenzhen, CN
amount percentile	10th of 414 (median 138, 0.2x median)
Peer records CSV (76 CN records)	🔒 Click to unlock →
CRM-ready export with official source URLs	🔒 Click to unlock →

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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-30
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd. and 76 CN peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

CN FDAPulse records like this one: 76
Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd.'s amount: 10th percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

41 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 30-day review: this device is a strong predicate for similar products.
Special 510(k): a modification of an existing device.
Posted 35 days ago.

What is the FDAPulse record for Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd.?

Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033) by Fussen Technology Co., Ltd. was cleared on 2026-09-30 after 30 days of review.

How does Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd. compare to other FDAPulse records?

Its amount of 30 is below the median (10th percentile); smaller records often move faster and face less competition. It is 35 days old, still within a typical 45-day follow-up window.

Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033) vs. top 3 peers

Organization	Location	Record date
Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033)	CN	2026-09-30
PV-iCurve Pro (K261531)	CN	2026-10-21
Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa	CN	2026-10-16
Single-Use EBUS Balloon (K261616)	CN	2026-10-15

How to monitor Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd. and peer radiology records

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