Exablate 4000 System
FDA premarket approval P150038/S007 · decided 2018-05-09
Approval details
- PMA number
- P150038
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Exablate 4000 System
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2018-04-23
- Decision date
- 2018-05-09
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Consolidate the two connector types of the 1.5T Head Coil cables into a single connector type (P-Type). The change is being made to maintain compatibility with the GE Medical Systems (GE) Signa Artist MR scanner.
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