Company ยท US
Adac Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2006. Name variants (Inc, Corp, punctuation) are merged.
88510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPS | System, Tomography, Computed, Emission | 35 |
| LLZ | System, Image Processing, Radiological | 14 |
| MUJ | System, Planning, Radiation Therapy Treatment | 9 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 7 |
| IYE | Accelerator, Linear, Medical | 6 |
| IYX | Camera, Scintillation (Gamma) | 6 |
| JAD | System, Therapeutic, X-Ray | 2 |
| JWM | System, Tomographic, Nuclear | 2 |
| IZI | System, X-Ray, Angiographic | 1 |
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 |
| KPQ | System, Simulation, Radiation Therapy | 1 |
| LEJ | Booth, Sun Tan | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 2006 | K062298 | APOLLO GAMMA CAMERA SYSTEM Adac Laboratories | KPS |
| May 1, 2006 | K061029 | JETSTREAM WORKSPACE Adac Laboratories | LLZ |
| Jan 20, 2006 | K060020 | AUTOQUANT PLUS Adac Laboratories | KPS |
| Jun 8, 2005 | K051351 | PRECEDENCE SPECT/CT IMAGING SYSTEM Adac Laboratories | KPS |
| Nov 3, 2004 | K042880 | JETSTREAM WORKSPACE Adac Laboratories | KPS |
| Oct 29, 2004 | K042903 | AUTOSPECS Adac Laboratories | KPS |
| Jun 25, 2004 | K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories | LNH |
| May 24, 2004 | K041218 | GRIFFIN SPECT/CT IMAGING SYSTEM Adac Laboratories | KPS |
| May 21, 2004 | K041182 | SYNTEGRA Adac Laboratories | KPS |
| Feb 25, 2004 | K040326 | AUTOQUANT PLUS Adac Laboratories | KPS |
| Feb 6, 2004 | K040142 | ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE Adac Laboratories | LLZ |
| Dec 12, 2003 | K033735 | VANTAGE PRO ATTENUATION CORRECTION DEVICE Adac Laboratories | KPS |
| Oct 22, 2003 | K033254 | FORTE GAMMA CAMERA SYSTEM Adac Laboratories | KPS |
| Oct 9, 2003 | K032724 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories | MUJ |
| Jun 20, 2003 | K031872 | ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] Adac Laboratories | KPS |
| Jun 17, 2003 | K031705 | SKYLIGHT IMAGING SYSTEM Adac Laboratories | KPS |
| Aug 6, 2002 | K022428 | QUANTITATIVE BLOOD POOL SPECT (QBS) Adac Laboratories | LLZ |
| Jun 5, 2002 | K021669 | PHYSICIAN'S DESKTOP REVIEW Adac Laboratories | LLZ |
| Nov 7, 2001 | K013521 | GEMINI IMAGING SYSTEM Adac Laboratories | JAK |
| Nov 6, 2001 | K013496 | MODIFICATION TO SKYLIGHT IMAGING SYSTEM Adac Laboratories | KPS |
| Feb 2, 2001 | K002237 | P3IMRT TM Adac Laboratories | MUJ |
| Nov 16, 2000 | K003434 | ALLEGRO TB, ALLEGRO N Adac Laboratories | KPS |
| Apr 7, 2000 | K993923 | ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM Adac Laboratories | MUJ |
| Apr 5, 2000 | K000908 | SKYLIGHT IMAGING SYSTEM Adac Laboratories | KPS |
| Mar 9, 2000 | K993946 | PEGASYS ULTRA Adac Laboratories | LLZ |
| Oct 1, 1999 | K992317 | AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION Adac Laboratories | KPS |
| Sep 1, 1999 | K992078 | VANTAGE EXSPECT II Adac Laboratories | KPS |
| Jul 26, 1999 | K991607 | VANTAGE 2.5 Adac Laboratories | KPS |
| Nov 16, 1998 | K982911 | FORTE Adac Laboratories | KPS |
| Jun 29, 1998 | K981291 | VANTAGE 3.0 INSYNCH Adac Laboratories | KPS |
| Jun 4, 1998 | K980867 | 3D-MSPECT Adac Laboratories | KPS |
| May 6, 1998 | K980715 | AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS) Adac Laboratories | KPS |
| Feb 24, 1998 | K974474 | PEGASYS INTOUCH Adac Laboratories | LLZ |
| Nov 26, 1997 | K973239 | DICOM 3.0 SOFTWARE VERSION 2.0 Adac Laboratories | LMD |
| Nov 25, 1997 | K973233 | IMAGE FUSION AND REVIEW SYSTEM Adac Laboratories | KPS |
| Oct 23, 1997 | K971980 | MCD-AC Adac Laboratories | KPS |
| Aug 8, 1997 | K971878 | VANTAGE 2.1 EXSPECT Adac Laboratories | KPS |
| Apr 8, 1996 | K951581 | PINNACLE3 APEX Adac Laboratories | IYE |
| Nov 24, 1995 | K952684 | VERTEX EPIC MCD Adac Laboratories | KPS |
| Nov 22, 1995 | K952564 | INSPECT/PROSPECT Adac Laboratories | KPS |
| Apr 26, 1995 | K943596 | VANTAGE, FOR ADAC GAMMA CAMERAS Adac Laboratories | KPS |
| Oct 4, 1994 | K926008 | PINNACLE 3 Adac Laboratories | IYE |
| Nov 2, 1993 | K931184 | MULTI-VIEW PROCESSOR (MVP) Adac Laboratories | IZI |
| Aug 5, 1993 | K932745 | C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS) Adac Laboratories | KPS |
| Jun 21, 1993 | K930283 | THYRUS Adac Laboratories | IYX |
| Jan 15, 1993 | K924878 | NEW DETECTOR OPTION Adac Laboratories | IYX |
| Jan 15, 1993 | K924639 | NEW DETECTOR FOR TRANSCAM/POLARIS S315 Adac Laboratories | IYX |
| Dec 7, 1992 | K924877 | OPTITRACK Adac Laboratories | KPS |
| Jul 17, 1992 | K922080 | GENESYS II Adac Laboratories | KPS |
| May 28, 1992 | K921296 | ADAC S315 Adac Laboratories, DK | IYX |
Newest 50 of 88.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | ADAC Laboratories Philips Pinnacle3 Version 6.4a Radiation Therapy Planning Software CD, Part Number 9104-0121B, Rev. A Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Planning Software Package (Kit), Model Number 9200-0613B-ENG Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Pinnacle3 Radiation Therapy Planning System, Version 6.6c CD, Part Number 9104-0121C Rev. A Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Pinnacle3 Radiation Therapy Planning System, Version 7.0e CD, Part Number Part # 9104-2011A Rev. A Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Pinnacle3 Radiation Therapy Planning System, Version 6.6c Kit, Model Number 9200-0613C-ENG Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Pinnacle3 Radiation Therapy Planning System, Version 7.0e Kit, Model Number 9200-9052A-ENG Terminated |
MUJ | K032724 |