DSP OPTION
FDA 510(k) clearance K945580 · decided 1995-01-30
Clearance details
- K-number
- K945580
- Device name
- DSP OPTION
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-14
- Decision date
- 1995-01-30
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- IZJ
- Device class
- 2
- Regulation number
- 892.1620
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medical Systems (Cleveland)
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CCD CAMERA, MODEL PKP-06000-000 (K024085) | Perkins Electronics Co. | 2003-03-11 |
| DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR (K972130) | Fairmontmedical | 1997-10-09 |
| PHILIPS DSI SYSTEM RELEASE 3.2 (K920793) | Philips Medical Systems, Inc. | 1992-07-17 |
| CINE CAMERA CONTROL MODEL PK2037 (K896615) | Perkins Mfg. Co. | 1990-01-04 |
| DTV-4114 FLUOROSCOPIC TELEVISION CAMERA (K881688) | Adac Laboratories | 1988-05-18 |
| CANON X-RAY 35MM CINE CAMERA CSI-35 (K853983) | Canon USA, Inc. | 1985-10-16 |
| VIDICAM 200 (K812613) | Diversified P.A. | 1981-12-08 |
| SIRCAM 103 (K810191) | Siemens Corp. | 1981-02-26 |
| 105MM ROLL FILM FLUOROGR. CAMERA, #105 (K810072) | Scientex Corp. | 1981-02-12 |
| 105MM SPOT FILM CAMERA (K802132) | Instrumentation Camera, Inc. | 1980-10-23 |
| SIRCAM 106 (K792394) | Siemens Corp. | 1979-12-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S019) | Philips Medical Systems (Cleveland), Inc. | 1988-07-27 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S022) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S021) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S018) | Philips Medical Systems (Cleveland), Inc. | 1988-06-13 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S017) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S015) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S016) | Philips Medical Systems (Cleveland), Inc. | 1988-04-28 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S014) | Philips Medical Systems (Cleveland), Inc. | 1988-04-26 |