Rapid MLS
510(k) K243378
Rapid MLS is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by iSchemaView, Inc., cleared under FDA 510(k) K243378 on 28 May 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243378 | Date28 May 2025 | StatusActive |
Official records
- FDA 510(k) database K243378
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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