Focus HD 35 Detector
Summary
Iray Technology Taicang , Ltd. received 510(k) clearance for Focus HD 35 Detector, a MQB device. Cleared on 2022-03-29.
Details
Source
510(k) Clearance
External ID
K213646
Action Date
2022-03-29
Status
Special
Category
device
Product Code
MQB
Product Description
Focus HD 35 Detector. Product code: MQB.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Iray Technology Taicang , Ltd. has received 10 total clearances in our database.
Iray Technology Taicang , Ltd. has 10 FDA actions in our database, including 10 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Iray Technology Taicang , Ltd. have FDA actions?
Iray Technology Taicang , Ltd. has 10 FDA actions in our database, including 0 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213646" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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