The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Ds Anterior, Ds Base, Ds Head-neck, Ds Head, Flex (s,m,l).
| Device ID | K123492 |
| 510k Number | K123492 |
| Device Name: | DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | PHILIPS MEDICAL SYSTEMS 3545 S W 47TH AVENUE Gainesville, FL 32608 -1099 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson PHILIPS MEDICAL SYSTEMS 3545 S W 47TH AVENUE Gainesville, FL 32608 -1099 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2012-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086098 | K123492 | 000 |
| 00884838066946 | K123492 | 000 |
| 00884838066939 | K123492 | 000 |
| 00884838065567 | K123492 | 000 |
| 00884838065550 | K123492 | 000 |
| 00884838065543 | K123492 | 000 |
| 00884838065536 | K123492 | 000 |
| 00884838065529 | K123492 | 000 |
| 00884838065512 | K123492 | 000 |
| 00884838066984 | K123492 | 000 |
| 00884838067370 | K123492 | 000 |
| 00884838067394 | K123492 | 000 |
| 00884838086081 | K123492 | 000 |
| 00884838086074 | K123492 | 000 |
| 00884838086067 | K123492 | 000 |
| 00884838086050 | K123492 | 000 |
| 00884838086043 | K123492 | 000 |
| 00884838086036 | K123492 | 000 |
| 00884838086029 | K123492 | 000 |
| 00884838085916 | K123492 | 000 |
| 00884838065505 | K123492 | 000 |