Adac Laboratories: FDA filings under this applicant name
FDA lists 88 510(k) clearances under the applicant name “Adac Laboratories” (first 1978, latest 2006), across 17 product codes in 2 review panels. Median 510(k) review time under this name: 68 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 35 | 35 |
| LLZ | System, Image Processing, Radiological | 14 | 14 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 7 | 7 |
| IYE | Accelerator, Linear, Medical | 6 | 6 |
| IYX | Camera, Scintillation (Gamma) | 6 | 6 |
| MUJ | System, Planning, Radiation Therapy Treatment | 3 | 3 |
| JAD | System, Therapeutic, X-Ray | 2 | 2 |
| JWM | System, Tomographic, Nuclear | 2 | 2 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | 1 | 1 |
Plus 7 more product codes.
Review panels
- Radiology (82)
- General and Plastic Surgery (1)
Most recent Adac Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062298 | APOLLO GAMMA CAMERA SYSTEM | KPS | 2006-08-23 | 15 |
| K061029 | JETSTREAM WORKSPACE | LLZ | 2006-05-01 | 17 |
| K060020 | AUTOQUANT PLUS | KPS | 2006-01-20 | 16 |
| K051351 | PRECEDENCE SPECT/CT IMAGING SYSTEM | KPS | 2005-06-08 | 15 |
| K042880 | JETSTREAM WORKSPACE | KPS | 2004-11-03 | 15 |
| K042903 | AUTOSPECS | KPS | 2004-10-29 | 14 |
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | LNH | 2004-06-25 | 11 |
| K041218 | GRIFFIN SPECT/CT IMAGING SYSTEM | KPS | 2004-05-24 | 14 |
| K041182 | SYNTEGRA | KPS | 2004-05-21 | 15 |
| K040326 | AUTOQUANT PLUS | KPS | 2004-02-25 | 15 |
78 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-03-03.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Adac Laboratories (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Adac Laboratories?
FDA lists 88 510(k) clearances under the applicant name “Adac Laboratories” (first 1978, latest 2006), across 17 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Adac Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Adac Laboratories is 68 days.
Which FDA product codes appear under Adac Laboratories?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 35); LLZ (System, Image Processing, Radiological, 14); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 7).
Next steps
- See all 88 Adac Laboratories clearances with predicates and recalls
- Run predicate analysis for product code KPS, Adac Laboratories's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.