← FDA Medical Device Classifications

Device, Spot-Film

IXL · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1670

Classification

FDA Product Code

IXL

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 892.1670

Review panel

RA

Medical specialty

Radiology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

13

Registered establishments

6

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown