SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
FDA 510(k) clearance K905728 · decided 1991-03-15
Clearance details
- K-number
- K905728
- Device name
- SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
- Applicant
- Hewlett-Packard Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-24
- Decision date
- 1991-03-15
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- DPT
- Device class
- 2
- Regulation number
- 870.2120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Laser Speckle Imaging System (RFLSI CZW) (K233076) | Rwd Life Science Co., Ltd. | 2024-05-28 |
| SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 (K163339) | Spectralmd, Inc. | 2017-08-17 |
| moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager (K152749) | Moor Instruments, Ltd. | 2016-05-12 |
| Deltex Medical KDP72 Doppler Probe (K142932) | Deltex Medical Limited | 2015-01-22 |
| BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE (K132730) | Medtronic, Inc. | 2014-05-30 |
| BIO-PROBE TRANSDUCER (ADULT) (K133903) | Medtronic, Inc. | 2014-04-10 |
| MOORLDLS-BI LASER DOPPLER BURNS IMAGER (K132163) | Moor Instruments, Ltd. | 2014-01-29 |
| DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM (K124049) | Spectralmd, Inc. | 2013-04-18 |
| AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN (K123216) | Aimago SA | 2013-02-07 |
| MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (K122943) | Moor Instruments, Ltd. | 2013-01-03 |
| AIMAGO EASYLDI MICROCIRCULATION CAMERA (K121429) | Aimago SA | 2012-08-10 |
| PERICAM PSI (K120884) | Perimed AB | 2012-07-03 |
Recalls involving this device
No recalls on record reference this clearance.