Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Adac Laboratories — Predicate Candidate Screening
88 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
165 days90th percentile
88clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062298 | APOLLO GAMMA CAMERA SYSTEM | Adac Laboratories | 2006-08-23 | 15 | 24 |
| K061029 | JETSTREAM WORKSPACE | Adac Laboratories | 2006-05-01 | 17 | 0 |
| K060020 | AUTOQUANT PLUS | Adac Laboratories | 2006-01-20 | 16 | 0 |
| K051351 | PRECEDENCE SPECT/CT IMAGING SYSTEM | Adac Laboratories | 2005-06-08 | 15 | 1 |
| K042880 | JETSTREAM WORKSPACE | Adac Laboratories | 2004-11-03 | 15 | 0 |
| K042903 | AUTOSPECS | Adac Laboratories | 2004-10-29 | 14 | 0 |
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Adac Laboratories | 2004-06-25 | 11 | 7 |
| K041218 | GRIFFIN SPECT/CT IMAGING SYSTEM | Adac Laboratories | 2004-05-24 | 14 | 11 |
| K041182 | SYNTEGRA | Adac Laboratories | 2004-05-21 | 15 | 0 |
| K040326 | AUTOQUANT PLUS | Adac Laboratories | 2004-02-25 | 15 | 0 |
| K040142 | ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE | Adac Laboratories | 2004-02-06 | 15 | 0 |
| K033735 | VANTAGE PRO ATTENUATION CORRECTION DEVICE | Adac Laboratories | 2003-12-12 | 14 | 0 |
| K033254 | FORTE GAMMA CAMERA SYSTEM | Adac Laboratories | 2003-10-22 | 14 | 4 |
| K032724 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Adac Laboratories | 2003-10-09 | 36 | 1 |
| K031872 | ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CAR | Adac Laboratories | 2003-06-20 | 3 | 0 |
| K031705 | SKYLIGHT IMAGING SYSTEM | Adac Laboratories | 2003-06-17 | 15 | 0 |
| K022428 | QUANTITATIVE BLOOD POOL SPECT (QBS) | Adac Laboratories | 2002-08-06 | 12 | 0 |
| K021669 | PHYSICIAN'S DESKTOP REVIEW | Adac Laboratories | 2002-06-05 | 15 | 0 |
| K013521 | GEMINI IMAGING SYSTEM | Adac Laboratories | 2001-11-07 | 15 | 2 |
| K013496 | MODIFICATION TO SKYLIGHT IMAGING SYSTEM | Adac Laboratories | 2001-11-06 | 15 | 0 |
| K002237 | P3IMRT TM | Adac Laboratories | 2001-02-02 | 193 | 0 |
| K003434 | ALLEGRO TB, ALLEGRO N | Adac Laboratories | 2000-11-16 | 10 | 0 |
| K993923 | ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM | Adac Laboratories | 2000-04-07 | 141 | 0 |
| K000908 | SKYLIGHT IMAGING SYSTEM | Adac Laboratories | 2000-04-05 | 15 | 13 |
| K993946 | PEGASYS ULTRA | Adac Laboratories | 2000-03-09 | 111 | 0 |
| K992317 | AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION | Adac Laboratories | 1999-10-01 | 84 | 0 |
| K992078 | VANTAGE EXSPECT II | Adac Laboratories | 1999-09-01 | 75 | 0 |
| K991607 | VANTAGE 2.5 | Adac Laboratories | 1999-07-26 | 77 | 0 |
| K982911 | FORTE | Adac Laboratories | 1998-11-16 | 90 | 3 |
| K981291 | VANTAGE 3.0 INSYNCH | Adac Laboratories | 1998-06-29 | 81 | 0 |
| K980867 | 3D-MSPECT | Adac Laboratories | 1998-06-04 | 90 | 0 |
| K980715 | AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE | Adac Laboratories | 1998-05-06 | 71 | 0 |
| K974474 | PEGASYS INTOUCH | Adac Laboratories | 1998-02-24 | 90 | 0 |
| K973239 | DICOM 3.0 SOFTWARE VERSION 2.0 | Adac Laboratories | 1997-11-26 | 90 | 0 |
| K973233 | IMAGE FUSION AND REVIEW SYSTEM | Adac Laboratories | 1997-11-25 | 89 | 0 |
| K971980 | MCD-AC | Adac Laboratories | 1997-10-23 | 147 | 0 |
| K971878 | VANTAGE 2.1 EXSPECT | Adac Laboratories | 1997-08-08 | 79 | 0 |
| K951581 | PINNACLE3 APEX | Adac Laboratories | 1996-04-08 | 370 | 0 |
| K952684 | VERTEX EPIC MCD | Adac Laboratories | 1995-11-24 | 165 | 2 |
| K952564 | INSPECT/PROSPECT | Adac Laboratories | 1995-11-22 | 173 | 0 |
| K943596 | VANTAGE, FOR ADAC GAMMA CAMERAS | Adac Laboratories | 1995-04-26 | 275 | 0 |
| K926008 | PINNACLE 3 | Adac Laboratories | 1994-10-04 | 676 | 0 |
| K931184 | MULTI-VIEW PROCESSOR (MVP) | Adac Laboratories | 1993-11-02 | 238 | 0 |
| K932745 | C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS) | Adac Laboratories | 1993-08-05 | 58 | 0 |
| K930283 | THYRUS | Adac Laboratories | 1993-06-21 | 151 | 0 |
| K924878 | NEW DETECTOR OPTION | Adac Laboratories | 1993-01-15 | 136 | 0 |
| K924639 | NEW DETECTOR FOR TRANSCAM/POLARIS S315 | Adac Laboratories | 1993-01-15 | 135 | 0 |
| K924877 | OPTITRACK | Adac Laboratories | 1992-12-07 | 84 | 0 |
| K922080 | GENESYS II | Adac Laboratories | 1992-07-17 | 74 | 2 |
| K921296 | ADAC S315 | Adac Laboratories | 1992-05-28 | 72 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda